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出境医 / 临床实验 / Peripheral Artery Disease in Patients With Stable Coronary Artery Disease in General Practice: Prevalence, Management and Clinical Outcomes. (PAD&CAD)
Peripheral Artery Disease in Patients With Stable Coronary Artery Disease in General Practice: Prevalence, Management and Clinical Outcomes. (PAD&CAD)
Study Description
Brief Summary:
Patients with lower extremity peripheral artery disease (PAD) are at risk of developing major adverse limb events and have a similar cardiovascular (CV) morbidity and mortality to those with coronary artery disease (CAD) with which is associated in most cases with a more severe prognosis. Because of higher risk conferred by concomitant PAD an early diagnosis is recommended in subjects with CAD. PAD can be diagnosed relatively easily and noninvasively with the ankle-brachial index (ABI) measure. An ABI ≤0.9 is an indicator of the presence of lower extremity PAD, indicating athero-occlusive arterial disease while >1.3/1.4 indicates an incompressible ankle arteries. However, ABI is not routinely applied in the clinical practice. Data on prevalence of PAD are scanty and in patients with stable CAD are lacking. The under-diagnosis of PAD may be a barrier to the use of treatments to improve prognosis. The primary aim of this study is to assess the coexistence of PAD in subjects with stable CAD and to evaluate the management and the prognosis of these patients in primary care at 12-month after the inclusion in the study.
| Condition or disease | Intervention/treatment |
|---|---|
| Peripheral Artery Disease | Diagnostic Test: ABI measurement |
Detailed Description:
National, multicentre, observational, prospective study. This study will be carried out with the collaboration with Study Center for Primary Care and with the Italian Society of Angiology and Vascular Medicine (SIAPAV).
The eligible patients with stable CAD will be called by General Practitioners (GPs).
For all patients who agree to participate in the study and sign the consent, two visits will be done at baseline and after 12 months.
At baseline will be collected information on socio-demographic and anthropometric data, blood pressure, heart rate, CV risk factors, medical history, lifestyle habits, PAD stage (for patient with abnormal ABI) and pharmacological therapy. ABI measurement will be done using an automatic simple device. In case of abnormal ABI value, a SIAPAV vascular specialist, at GP's office, will confirm it using the standard manual continuous wave (CW) Doppler.
At follow-up visit the following information will be collected the: referral to vascular specialist (if requested, at discretion of the GP), relevant change in pharmacological therapy, major CV events and progression of PAD, limb and coronary artery revascularizations, amputations, major bleeding, and death.
Study Design
| Study Type : | Observational |
| Estimated Enrollment : | 1000 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Peripheral Artery Disease in Patients With Stable Coronary Artery Disease in General Practice: Prevalence, Management and Clinical Outcomes. |
| Actual Study Start Date : | September 25, 2019 |
| Estimated Primary Completion Date : | November 25, 2020 |
| Estimated Study Completion Date : | July 21, 2021 |
Arms and Interventions
| Group/Cohort | Intervention/treatment |
|---|---|
|
Patients with CAD
In this study will be included patients with stable CAD
|
Diagnostic Test: ABI measurement
ABI measurement wil be done with an automatic device to diagnose PAD in patients with CAD
|
Outcome Measures
Primary Outcome Measures :
- To know the prevalence of PAD in patients with CAD using the automatic device MESI ankle-brachial pressure index (ABPI) MD® [ Time Frame: 1 day ]The prevalence of PAD will be diagnosed measuring the ankle-brachial-index (ABI) determined by dividing the higher systolic pressure measured at the ankle of both legs by the brachial arterial systolic pressure. An ABI value <=0.9 is an indicator of the presence of PAD indicating athero-occlusive arterial disease while >1.3/1.4 indicates an incompressible ankle arteries. The ABI measurement will be performed using the automatic device MESI ABPI MD.
Secondary Outcome Measures :
- To measure the Blood pressure (mmHg) [ Time Frame: 1 day ]
- To measure the Heart rate (bpm) [ Time Frame: 1 day ]
- To measure the Weight (kg) [ Time Frame: 1 day ]
- To measure the Height (cm) [ Time Frame: 1 day ]
- To measure the Body mass index (Kg/m2) [ Time Frame: 1 day ]
- To measure the Ankle Brachial Index (ABI) Value [ Time Frame: 1 day ]
- Clinical History of Limb peripheral artery revascularization [ Time Frame: 1 day ]
- Clinical History of Limb or foot amputation for arterial vascular disease [ Time Frame: 1 day ]
- Clinical History of Clinical presentation of lower extremity disease [ Time Frame: 1 day ]
- Clinical History of Aortic aneurysm [ Time Frame: 1 day ]
- Clinical History of Carotid artery stenosis [ Time Frame: 1 day ]
- Clinical History of Heart Failure [ Time Frame: 1 day ]
- Clinical History of Atrial Fibrillation or Flutter [ Time Frame: 1 day ]
- Clinical History of Hypertension [ Time Frame: 1 day ]
- Clinical History of Dyslipidemia [ Time Frame: 1 day ]
- Clinical History of Chronic Kidney disease [ Time Frame: 1 day ]
- Clinical History of Stroke [ Time Frame: 1 day ]
- Clinical History of Transient ischemic attack [ Time Frame: 1 day ]
- Clinical History of Bleeding [ Time Frame: 1 day ]
- Clinical History of cancer [ Time Frame: 1 day ]
- The dietary habits [ Time Frame: 1 day ]The Mediterranean Diet Questionnaire (Prevention with a Mediterranean Diet PREDIMED -14 Items) will be administered
- Physical activity [ Time Frame: 1 day ]The Physical activity Questionnaire (BRFSS 2 items) will be administered
- Total cholesterol (mg/dL) [ Time Frame: 1 day ]
- LDL cholesterol (mg/dL) [ Time Frame: 1 day ]
- HDL cholesterol (mg/dL) [ Time Frame: 1 day ]
- Triglycerides (mg/dL) [ Time Frame: 1 day ]
- Glycemia (mg/dL) [ Time Frame: 1 day ]
- Glycated hemoglobin (only for patients with diabetes mellitus) (%) [ Time Frame: 1 day ]
- Creatinine (mg/dL) [ Time Frame: 1 day ]
- Alanine aminotransferase (ALT) (U/L) [ Time Frame: 1 day ]
- Aspartate aminotransferase (AST) (U/L) [ Time Frame: 1 day ]
- Hemoglobin (g/dL) [ Time Frame: 1 day ]
- Platelet count (x 103μL) [ Time Frame: 1 day ]
- Hematocrit (%) [ Time Frame: 1 day ]
- Red blood cells (x10^3 ml) [ Time Frame: 1 day ]
- White blood cells (x10^3 ml) [ Time Frame: 1 day ]
- Marital status [ Time Frame: 1 day ]
- Education Status [ Time Frame: 1 day ]
- Employment status [ Time Frame: 1 day ]
Other Outcome Measures:
- The incidence of Acute coronary syndrome [ Time Frame: 12 months ]
- The incidence of Stroke [ Time Frame: 12 months ]
- The incidence of Transient ischemic attack [ Time Frame: 12 months ]
- The incidence of Heart Failure [ Time Frame: 12 months ]
- The incidence of Atrial fibrillation or Flutter [ Time Frame: 12 months ]
- The incidence of Coronary artery revascularization [ Time Frame: 12 months ]
- The incidence of Hospitalization for worsening of PAD [ Time Frame: 12 months ]
- The incidence of Limb peripheral artery revascularization [ Time Frame: 12 months ]
- The incidence of Lower limb amputation for arterial vascular disease [ Time Frame: 12 months ]
- The incidence of Major bleeding (bleeding leading to hospitalization, bleeding requiring surgical procedures to manage the bleeding, bleeding requiring blood trabsfusion) [ Time Frame: 12 months ]
Eligibility Criteria
| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients with a diagnosis of stable CAD in charge of GPs, giving the consent to participate in the study.
Criteria
Inclusion Criteria:
- Patients of both sexes with a diagnosis of stable CAD as follows: acute myocardial infarction or percutaneous coronary revascularization or coronary artery bypass graft surgery occured at least 12 months before entering the study or chronic stable angina.
Exclusion Criteria:
- Mental illness limiting the capacity of self-care or any condition limiting seriously the life expectancy less than 12 months.
Contacts and Locations
Contacts
| Contact: Marta Baviera, PharmD | +390239014 ext 633 | marta.baviera@marionegri.it |
Locations
| Italy | |
| MEDICOOP Genova | Not yet recruiting |
| Genova, GE, Italy, 16165 | |
| Contact: Pierclaudio Brasesco, MD +393356593590 brasesco@fastwebnet.it | |
| Cooperativa Medici Milano Centro | Recruiting |
| Milan, MI, Italy, 20154 | |
| Contact: Alberto Aronica, MD +393356415072 albertoaronica@gmail.com | |
| MEDICOOP S. Agata | Not yet recruiting |
| Reggio Calabria, RC, Italy, 89134 | |
| Contact: Quinto Campolo, MD +393385756989 quintocampolo@virgilio.it | |
| ROMAMED Service | Recruiting |
| Rome, RM, Italy, 00137 | |
| Contact: Antonio CALICCHIA, MD +390688970 ext 322 dr_anto_17@hotmail.it | |
Sponsors and Collaborators
Mario Negri Institute for Pharmacological Research
Investigators
| Study Director: | Marta Baviera, PharmD | Istituto di Ricerche Farmacologiche Mario Negri IRCCS |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | April 1, 2019 | ||||
| First Posted Date | April 19, 2019 | ||||
| Last Update Posted Date | October 26, 2020 | ||||
| Actual Study Start Date | September 25, 2019 | ||||
| Estimated Primary Completion Date | November 25, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
To know the prevalence of PAD in patients with CAD using the automatic device MESI ankle-brachial pressure index (ABPI) MD® [ Time Frame: 1 day ] The prevalence of PAD will be diagnosed measuring the ankle-brachial-index (ABI) determined by dividing the higher systolic pressure measured at the ankle of both legs by the brachial arterial systolic pressure. An ABI value <=0.9 is an indicator of the presence of PAD indicating athero-occlusive arterial disease while >1.3/1.4 indicates an incompressible ankle arteries. The ABI measurement will be performed using the automatic device MESI ABPI MD.
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures |
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| Current Other Pre-specified Outcome Measures |
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| Original Other Pre-specified Outcome Measures |
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| Descriptive Information | |||||
| Brief Title | Peripheral Artery Disease in Patients With Stable Coronary Artery Disease in General Practice: Prevalence, Management and Clinical Outcomes. | ||||
| Official Title | Peripheral Artery Disease in Patients With Stable Coronary Artery Disease in General Practice: Prevalence, Management and Clinical Outcomes. | ||||
| Brief Summary | Patients with lower extremity peripheral artery disease (PAD) are at risk of developing major adverse limb events and have a similar cardiovascular (CV) morbidity and mortality to those with coronary artery disease (CAD) with which is associated in most cases with a more severe prognosis. Because of higher risk conferred by concomitant PAD an early diagnosis is recommended in subjects with CAD. PAD can be diagnosed relatively easily and noninvasively with the ankle-brachial index (ABI) measure. An ABI ≤0.9 is an indicator of the presence of lower extremity PAD, indicating athero-occlusive arterial disease while >1.3/1.4 indicates an incompressible ankle arteries. However, ABI is not routinely applied in the clinical practice. Data on prevalence of PAD are scanty and in patients with stable CAD are lacking. The under-diagnosis of PAD may be a barrier to the use of treatments to improve prognosis. The primary aim of this study is to assess the coexistence of PAD in subjects with stable CAD and to evaluate the management and the prognosis of these patients in primary care at 12-month after the inclusion in the study. | ||||
| Detailed Description |
National, multicentre, observational, prospective study. This study will be carried out with the collaboration with Study Center for Primary Care and with the Italian Society of Angiology and Vascular Medicine (SIAPAV). The eligible patients with stable CAD will be called by General Practitioners (GPs). For all patients who agree to participate in the study and sign the consent, two visits will be done at baseline and after 12 months. At baseline will be collected information on socio-demographic and anthropometric data, blood pressure, heart rate, CV risk factors, medical history, lifestyle habits, PAD stage (for patient with abnormal ABI) and pharmacological therapy. ABI measurement will be done using an automatic simple device. In case of abnormal ABI value, a SIAPAV vascular specialist, at GP's office, will confirm it using the standard manual continuous wave (CW) Doppler. At follow-up visit the following information will be collected the: referral to vascular specialist (if requested, at discretion of the GP), relevant change in pharmacological therapy, major CV events and progression of PAD, limb and coronary artery revascularizations, amputations, major bleeding, and death. |
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| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients with a diagnosis of stable CAD in charge of GPs, giving the consent to participate in the study. | ||||
| Condition | Peripheral Artery Disease | ||||
| Intervention | Diagnostic Test: ABI measurement
ABI measurement wil be done with an automatic device to diagnose PAD in patients with CAD
|
||||
| Study Groups/Cohorts | Patients with CAD
In this study will be included patients with stable CAD
Intervention: Diagnostic Test: ABI measurement
|
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| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Recruiting | ||||
| Estimated Enrollment |
1000 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | July 21, 2021 | ||||
| Estimated Primary Completion Date | November 25, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender |
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| Ages | Child, Adult, Older Adult | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts |
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| Listed Location Countries | Italy | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03921905 | ||||
| Other Study ID Numbers | IRFMN-7825 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Mario Negri Institute for Pharmacological Research | ||||
| Study Sponsor | Mario Negri Institute for Pharmacological Research | ||||
| Collaborators | Not Provided | ||||
| Investigators |
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| PRS Account | Mario Negri Institute for Pharmacological Research | ||||
| Verification Date | October 2020 | ||||
