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出境医 / 临床实验 / Lifestyle Modification Programme for Patients With Asymptomatic Carotid Artery Stenosis

Lifestyle Modification Programme for Patients With Asymptomatic Carotid Artery Stenosis

Study Description
Brief Summary:
This study randomises patients with patients with asymptomatic carotid artery stenosis, to be managed either by providing an intensive 12-week lifestyle modification programme, or standard healthcare.

Condition or disease Intervention/treatment Phase
Carotid Stenosis Behavioral: Risk Factors Modification Programme Behavioral: Standard Care Not Applicable

Detailed Description:

Cardiovascular disease (CVD) is the leading cause of mortality and acquired disability globally. According to the World Health Organisation (WHO), 30% of total global deaths are due to CVD, and approximately 6 million deaths result from cerebrovascular disease.

A common cause of cerebrovascular disease is internal carotid artery stenosis. Despite recent advances in carotid artery revascularisation, risk factor modification remains the cornerstone of therapy for this devastating disease. According to the European Society of Cardiology (ESC), the lifestyle risk factors for vascular diseases include; cigarette smoking, physical inactivity, increased body mass index, and unhealthy diet, and stress, while the medical risk factors include; High blood pressure, elevated blood sugar, and hyperlipidaemia. All these factors have been identified in several studies as significant modifiable risk factors that should be targeted for preventing morbidity and mortality resulting from cerebrovascular disease.

Previous studies indicated that modifiable risk factor programmes can help cardiac patients to achieve their risk factor modification targets. However, to date there do not seem to be any studies assessing the outcomes of a multidisciplinary risk factor modification programme in patients with carotid artery stenosis. Our study will evaluate the impact of an intensive 12-week, multidisciplinary risk factors modification programme on medical and lifestyle risk factors modification, as well as on risk reduction for stroke and cardiovascular events, among patients with asymptomatic carotid artery stenosis. We will compare these outcomes to that of standard care traditionally provided to this high-risk patient group.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 208 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a randomised, parallel group, active-control trial, with patients randomised in a 1:1 ratio to one of two treatment arms.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Blinding of trial participants and care providers is not possible because of obvious differences between the interventions. However, the investigator, the outcomes assessor and statistician are blinded to treatment received.
Primary Purpose: Treatment
Official Title: Intensive Lifestyle Modification Programme Versus Standard Care for Risk Factor Reduction and Stroke Prevention in Patients With Asymptomatic Carotid Artery Stenosis. A Prospective Randomised Controlled Trial
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : June 1, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: Risk Factors Modification Programme
  • Patients in the intervention arm will attend the 12-week intensive lifestyle programme which includes healthy lifestyle change such as smoking cessation, healthy food choices and increasing physical activity levels, as well as management of cholesterol, diabetes, and blood pressure.
  • The 12-week programme will consist of 12 sessions of 2.5 hours each per week.
  • Each of the weekly sessions will incorporate an individualised meeting between the multidisciplinary healthcare team and each patient to review the progress and health goals.
  • The weekly sessions will also include a one-hour group exercise programme and an educational workshop.
 Behavioral: Risk Factors Modification Programme
12-week supervised risk factor modification programme derived from the EuroAction Study standards.
Active Comparator: Standard Care
Standard care is defined as giving information and advice to the patients to modify their lifestyles but without providing a structured intervention or an individualised plan.
 Behavioral: Standard Care
Patients advised to adjust lifestyle without the support of the structured supervised programme.
Outcome Measures
Primary Outcome Measures :
  1. Achieve Lifestyle modification target [ Time Frame: 12 weeks ]

    This is a composite primary endpoint. The patient will be considered to have achieved the composite primary endpoint if they achieve any one or more of the following targets:

    1. Smoking cessation.
    2. Body Mass Index (BMI) between 20 to 25 kg/m^2. BMI is calculated by dividing body weight in kilograms by the square of height in metres.
    3. Glycosylated Haemoglobin (HbA1C) less than 7%.


Secondary Outcome Measures :
  1. Cardiovascular events [ Time Frame: 1 year ]
    Any of cerebrovascular events (Transient ischaemic attack or stroke), myocardial infarction, or death.

  2. Changes in the degree of carotid artery stenosis [ Time Frame: 1 year ]
    Any increase or decrease in the percentage of internal carotid artery stenosis, documented by duplex scan.

  3. Carotid artery revascularisation [ Time Frame: 1 year ]
    Any need for carotid endarterectomy or carotid stenting, with any documented procedure complications.

  4. Re-intervention rates [ Time Frame: 1 year ]
    Any re-intervention among patients who already underwent carotid revascularisation procedures.

  5. Change in cognitive function [ Time Frame: 1 year ]

    Assessed using the Mini-Mental State Examination (MMSE) at enrolment and after one year.

    The Mini-Mental State Examination (MMSE) is a validated 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment, patient's orientation, attention, memory, language, and visual-spatial skills.

    The maximum score is 30 points (out of 30). Any score greater than or equal to 24 points (out of 30) indicates a normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment. Moderate to low scores correlate closely with the presence of dementia. A version of the MMSE questionnaire can be found on the British Columbia Ministry of Health website.


  6. Change in quality of life [ Time Frame: 1 year ]

    Assessed using the Dartmouth Cooperative Information Project (COOP) charts at enrolment and after one year.

    The COOP charts measure six core aspects of functional status: physical fitness, feelings, daily activities, social activities, change in health, pain, and overall health. The instrument consists of six charts, referring to the above mentioned aspects of functioning. Each chart consists of a simple title, a question referring to the status of the patient and an ordinal five-point response scale illustrated with a simple drawing.

    Each item is rated on this five-point ordinal scale ranging from 1 (no limitation at all) to 5 (severely limited); for 'change in health' score 1 means 'much better' and score 5 'much worse'. The designers do not advocate summing the responses to gain a single index figure of health status.



Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults aged 18 years or more.
  • Provide written informed consent.
  • History of asymptomatic carotid artery stenosis, defined as a stenosis of the internal carotid artery of 50% or higher, but without history of any cerebrovascular events within the previous 6 months.

  • Patients should have at least one of the following risk factors:

    1. Blood pressure > 140/80 mmHg
    2. Fasting blood sugar > 53 mmol/mol (HbA1c > 7%)
    3. Total cholesterol > 5 mmol/l
    4. Low-density lipoprotein (LDL) cholesterol > 2.6 mmol/l
    5. Triglycerides > 1.7 mmol/l
    6. High-density lipoprotein (HDL) cholesterol ˂ 1.2 mmol/l in females, and ˂ 1 mmol/l in males.
    7. Body mass index (BMI) > 25 kg/m^2.
    8. Waist circumference of > 80 cm in women, and > 94 cm in men.
    9. Mediterranean diet score < 12
    10. Physically inactive.
    11. Current smoker or exposure to tobacco in any form.

Exclusion Criteria:

  • Patients with symptomatic carotid stenosis and with a documented symptomatic cerebrovascular event. A cerebrovascular event is considered if the patient experienced any of an amaurosis fugax, transient ischaemic attack (TIA), or stroke within the past 6 months.
  • Significant cognitive impairment or mental illness.
  • Currently pregnant women (confirmed by β-Human chorionic gonadotropin (HCG) analysis).
  • Inadequate English language ability to understand the content of the intervention programme.
  • Involvement in another clinical trial in the previous six months.
  • Legal incapacity.
  • Patient is bed-ridden or immobile.
  • Contraindication to antiplatelet or anticoagulation therapy, or any of risk factor medications.
  • Presence of any illness that could limit long-term compliance.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Wael Tawfick, MB BcH,MRCSI + 35391542535 wael.tawfick@hse.ie
Contact: Sherif Sultan, MD, FRCSI +35391542534 sherif.sultan@hse.ie

Locations
Layout table for location information
Ireland
Department of Vascular Surgery, Western Vascular Institute, Galway University Hospital Recruiting
Galway, Ireland
Contact: Sherif Sultan, MD    +35391542534    sherif.sultan@hse.ie   
Contact: Wael Tawfick, MD    +35391542535    wael.tawfick@hse.ie   
Sponsors and Collaborators
Western Vascular Institute, Ireland
Investigators
Layout table for investigator information
Principal Investigator: Wael Tawfick, MB BcH,MRCSI Western Vascular Institute, Ireland
Principal Investigator: Sherif Sultan, MD, FRCSI Western Vascular Institute, Ireland
Study Director: Abdelsalam BenSaaud, MB BcH, MSc Western Vascular Institute, Ireland
Tracking Information
First Submitted Date  ICMJE December 19, 2018
First Posted Date  ICMJE April 26, 2019
Last Update Posted Date April 26, 2019
Actual Study Start Date  ICMJE June 1, 2018
Estimated Primary Completion Date September 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2019) 		Achieve Lifestyle modification target [ Time Frame: 12 weeks ]
This is a composite primary endpoint. The patient will be considered to have achieved the composite primary endpoint if they achieve any one or more of the following targets:
  1. Smoking cessation.
  2. Body Mass Index (BMI) between 20 to 25 kg/m^2. BMI is calculated by dividing body weight in kilograms by the square of height in metres.
  3. Glycosylated Haemoglobin (HbA1C) less than 7%.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2019)
  • Cardiovascular events [ Time Frame: 1 year ]
    Any of cerebrovascular events (Transient ischaemic attack or stroke), myocardial infarction, or death.
  • Changes in the degree of carotid artery stenosis [ Time Frame: 1 year ]
    Any increase or decrease in the percentage of internal carotid artery stenosis, documented by duplex scan.
  • Carotid artery revascularisation [ Time Frame: 1 year ]
    Any need for carotid endarterectomy or carotid stenting, with any documented procedure complications.
  • Re-intervention rates [ Time Frame: 1 year ]
    Any re-intervention among patients who already underwent carotid revascularisation procedures.
  • Change in cognitive function [ Time Frame: 1 year ]
    Assessed using the Mini-Mental State Examination (MMSE) at enrolment and after one year. The Mini-Mental State Examination (MMSE) is a validated 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment, patient's orientation, attention, memory, language, and visual-spatial skills. The maximum score is 30 points (out of 30). Any score greater than or equal to 24 points (out of 30) indicates a normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment. Moderate to low scores correlate closely with the presence of dementia. A version of the MMSE questionnaire can be found on the British Columbia Ministry of Health website.
  • Change in quality of life [ Time Frame: 1 year ]
    Assessed using the Dartmouth Cooperative Information Project (COOP) charts at enrolment and after one year. The COOP charts measure six core aspects of functional status: physical fitness, feelings, daily activities, social activities, change in health, pain, and overall health. The instrument consists of six charts, referring to the above mentioned aspects of functioning. Each chart consists of a simple title, a question referring to the status of the patient and an ordinal five-point response scale illustrated with a simple drawing. Each item is rated on this five-point ordinal scale ranging from 1 (no limitation at all) to 5 (severely limited); for 'change in health' score 1 means 'much better' and score 5 'much worse'. The designers do not advocate summing the responses to gain a single index figure of health status.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lifestyle Modification Programme for Patients With Asymptomatic Carotid Artery Stenosis
Official Title  ICMJE Intensive Lifestyle Modification Programme Versus Standard Care for Risk Factor Reduction and Stroke Prevention in Patients With Asymptomatic Carotid Artery Stenosis. A Prospective Randomised Controlled Trial
Brief Summary This study randomises patients with patients with asymptomatic carotid artery stenosis, to be managed either by providing an intensive 12-week lifestyle modification programme, or standard healthcare.
Detailed Description

Cardiovascular disease (CVD) is the leading cause of mortality and acquired disability globally. According to the World Health Organisation (WHO), 30% of total global deaths are due to CVD, and approximately 6 million deaths result from cerebrovascular disease.

A common cause of cerebrovascular disease is internal carotid artery stenosis. Despite recent advances in carotid artery revascularisation, risk factor modification remains the cornerstone of therapy for this devastating disease. According to the European Society of Cardiology (ESC), the lifestyle risk factors for vascular diseases include; cigarette smoking, physical inactivity, increased body mass index, and unhealthy diet, and stress, while the medical risk factors include; High blood pressure, elevated blood sugar, and hyperlipidaemia. All these factors have been identified in several studies as significant modifiable risk factors that should be targeted for preventing morbidity and mortality resulting from cerebrovascular disease.

Previous studies indicated that modifiable risk factor programmes can help cardiac patients to achieve their risk factor modification targets. However, to date there do not seem to be any studies assessing the outcomes of a multidisciplinary risk factor modification programme in patients with carotid artery stenosis. Our study will evaluate the impact of an intensive 12-week, multidisciplinary risk factors modification programme on medical and lifestyle risk factors modification, as well as on risk reduction for stroke and cardiovascular events, among patients with asymptomatic carotid artery stenosis. We will compare these outcomes to that of standard care traditionally provided to this high-risk patient group.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
This is a randomised, parallel group, active-control trial, with patients randomised in a 1:1 ratio to one of two treatment arms.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description:
Blinding of trial participants and care providers is not possible because of obvious differences between the interventions. However, the investigator, the outcomes assessor and statistician are blinded to treatment received.
Primary Purpose: Treatment
Condition  ICMJE Carotid Stenosis
Intervention  ICMJE
  • Behavioral: Risk Factors Modification Programme
    12-week supervised risk factor modification programme derived from the EuroAction Study standards.
  • Behavioral: Standard Care
    Patients advised to adjust lifestyle without the support of the structured supervised programme.
Study Arms  ICMJE
  • Experimental: Risk Factors Modification Programme
    • Patients in the intervention arm will attend the 12-week intensive lifestyle programme which includes healthy lifestyle change such as smoking cessation, healthy food choices and increasing physical activity levels, as well as management of cholesterol, diabetes, and blood pressure.
    • The 12-week programme will consist of 12 sessions of 2.5 hours each per week.
    • Each of the weekly sessions will incorporate an individualised meeting between the multidisciplinary healthcare team and each patient to review the progress and health goals.
    • The weekly sessions will also include a one-hour group exercise programme and an educational workshop.
    Intervention: Behavioral: Risk Factors Modification Programme
  • Active Comparator: Standard Care
    Standard care is defined as giving information and advice to the patients to modify their lifestyles but without providing a structured intervention or an individualised plan.
    Intervention: Behavioral: Standard Care
Publications *
  • Perk J, De Backer G, Gohlke H, Graham I, Reiner Z, Verschuren WM, Albus C, Benlian P, Boysen G, Cifkova R, Deaton C, Ebrahim S, Fisher M, Germanò G, Hobbs R, Hoes A, Karadeniz S, Mezzani A, Prescott E, Ryden L, Scherer M, Syvanne M, Scholte Op Reimer WJ, Vrints C, Wood D, Zamorano JL, Zannad F; Comitato per Linee Guida Pratiche (CPG) dell'ESC. [European Guidelines on Cardiovascular Disease Prevention in Clinical Practice (version 2012). The Fifth Joint Task Force of the European Society of Cardiology and other societies on cardiovascular disease prevention in clinical practice (constituted by representatives of nine societies and by invited experts)]. G Ital Cardiol (Rome). 2013 May;14(5):328-92. doi: 10.1714/1264.13964. Italian.
  • Piepoli MF, Hoes AW, Agewall S, Albus C, Brotons C, Catapano AL, Cooney MT, Corrà U, Cosyns B, Deaton C, Graham I, Hall MS, Hobbs FDR, Løchen ML, Löllgen H, Marques-Vidal P, Perk J, Prescott E, Redon J, Richter DJ, Sattar N, Smulders Y, Tiberi M, van der Worp HB, van Dis I, Verschuren WMM. [2016 European guidelines on cardiovascular disease prevention in clinical practice. The Sixth Joint Task Force of the European Society of Cardiology and Other Societies on Cardiovascular Disease Prevention in Clinical Practice (constituted by representatives of 10 societies and by invited experts. Developed with the special contribution of the European Association for Cardiovascular Prevention & Rehabilitation]. G Ital Cardiol (Rome). 2017 Jul-Aug;18(7):547-612. doi: 10.1714/2729.27821. Italian.
  • Kaikkonen JE, Mikkilä V, Magnussen CG, Juonala M, Viikari JS, Raitakari OT. Does childhood nutrition influence adult cardiovascular disease risk?--insights from the Young Finns Study. Ann Med. 2013 Mar;45(2):120-8. doi: 10.3109/07853890.2012.671537. Epub 2012 Apr 12. Review.
  • de Lorgeril M, Salen P, Martin JL, Monjaud I, Delaye J, Mamelle N. Mediterranean diet, traditional risk factors, and the rate of cardiovascular complications after myocardial infarction: final report of the Lyon Diet Heart Study. Circulation. 1999 Feb 16;99(6):779-85.
  • Iaccarino Idelson P, Scalfi L, Valerio G. Adherence to the Mediterranean Diet in children and adolescents: A systematic review. Nutr Metab Cardiovasc Dis. 2017 Apr;27(4):283-299. doi: 10.1016/j.numecd.2017.01.002. Epub 2017 Jan 12. Review.
  • Yusuf S, Hawken S, Ounpuu S, Dans T, Avezum A, Lanas F, McQueen M, Budaj A, Pais P, Varigos J, Lisheng L; INTERHEART Study Investigators. Effect of potentially modifiable risk factors associated with myocardial infarction in 52 countries (the INTERHEART study): case-control study. Lancet. 2004 Sep 11-17;364(9438):937-52.
  • Wood DA, Kotseva K, Connolly S, Jennings C, Mead A, Jones J, Holden A, De Bacquer D, Collier T, De Backer G, Faergeman O; EUROACTION Study Group. Nurse-coordinated multidisciplinary, family-based cardiovascular disease prevention programme (EUROACTION) for patients with coronary heart disease and asymptomatic individuals at high risk of cardiovascular disease: a paired, cluster-randomised controlled trial. Lancet. 2008 Jun 14;371(9629):1999-2012. doi: 10.1016/S0140-6736(08)60868-5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 23, 2019) 		208
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2021
Estimated Primary Completion Date September 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adults aged 18 years or more.
  • Provide written informed consent.
  • History of asymptomatic carotid artery stenosis, defined as a stenosis of the internal carotid artery of 50% or higher, but without history of any cerebrovascular events within the previous 6 months.

  • Patients should have at least one of the following risk factors:

    1. Blood pressure > 140/80 mmHg
    2. Fasting blood sugar > 53 mmol/mol (HbA1c > 7%)
    3. Total cholesterol > 5 mmol/l
    4. Low-density lipoprotein (LDL) cholesterol > 2.6 mmol/l
    5. Triglycerides > 1.7 mmol/l
    6. High-density lipoprotein (HDL) cholesterol ˂ 1.2 mmol/l in females, and ˂ 1 mmol/l in males.
    7. Body mass index (BMI) > 25 kg/m^2.
    8. Waist circumference of > 80 cm in women, and > 94 cm in men.
    9. Mediterranean diet score < 12
    10. Physically inactive.
    11. Current smoker or exposure to tobacco in any form.

Exclusion Criteria:

  • Patients with symptomatic carotid stenosis and with a documented symptomatic cerebrovascular event. A cerebrovascular event is considered if the patient experienced any of an amaurosis fugax, transient ischaemic attack (TIA), or stroke within the past 6 months.
  • Significant cognitive impairment or mental illness.
  • Currently pregnant women (confirmed by β-Human chorionic gonadotropin (HCG) analysis).
  • Inadequate English language ability to understand the content of the intervention programme.
  • Involvement in another clinical trial in the previous six months.
  • Legal incapacity.
  • Patient is bed-ridden or immobile.
  • Contraindication to antiplatelet or anticoagulation therapy, or any of risk factor medications.
  • Presence of any illness that could limit long-term compliance.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Ireland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03929354
Other Study ID Numbers  ICMJE WVI-CAS
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Individual participant data (IPD) of primary and secondary outcomes, could be made available to other researchers by request, while maintaining participant confidentiality
Responsible Party Western Vascular Institute, Ireland
Study Sponsor  ICMJE Western Vascular Institute, Ireland
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Wael Tawfick, MB BcH,MRCSI Western Vascular Institute, Ireland
Principal Investigator: Sherif Sultan, MD, FRCSI Western Vascular Institute, Ireland
Study Director: Abdelsalam BenSaaud, MB BcH, MSc Western Vascular Institute, Ireland
PRS Account Western Vascular Institute, Ireland
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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