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出境医 / 临床实验 / Novel Approaches of Advanced Neuroimaging Based on MRI Fiber Tracking to Detect Early Signs of Vascular Cognitive Impairment in Hypertensive Patients
Novel Approaches of Advanced Neuroimaging Based on MRI Fiber Tracking to Detect Early Signs of Vascular Cognitive Impairment in Hypertensive Patients
Study Description
Brief Summary:
Hypertension is the major risk factor for vascular cognitive impairment (VCI). One of the main limitations in the clinical approach to VCI is that, by the time that it is manifested, it might be too late to reverse the neurodegenerative process. Thus, early identification of predictive signs of later dementia is demanding for management of hypertensive patients (HT).This aim claims for new methods that compute in a cloud all possible data sources coming from patients (brain imaging, cognitive profile, clinical data), to extract discriminative aggregate biomarkers. Thus, this study aims at: 1) characterizing the predictive potential of an aggregate biomarker for dementia in HT, based on brain imaging, clinical and cognitive assessment; 2) evaluating the impact of blood pressure variability, besides systolic/diastolic blood pressure, on the progression of the aggregate biomarker; 3) assessing whether specific classes of antihypertensive drugs differently affect the progression of the aggregate biomarker. In order to do this, this study proposes to evaluate advanced brain imaging and cognitive profile in a cohort of hypertensive patients, at baseline and after a 1 year follow up, to identify an innovative signature for the development of cognitive dysfunction in hypertension. In particular, the effects of blood pressure variability and of different classes of antihypertensive drugs will be evaluated.
| Condition or disease | Intervention/treatment |
|---|---|
| Hypertension | Other: No interventions |
Study Design
| Study Type : | Observational |
| Estimated Enrollment : | 176 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Prospective |
| Official Title: | Novel Approaches of Advanced Neuroimaging Based on MRI Fiber Tracking to Detect Early Signs of Vascular Cognitive Impairment in Hypertensive Patients |
| Actual Study Start Date : | December 9, 2019 |
| Estimated Primary Completion Date : | December 8, 2022 |
| Estimated Study Completion Date : | December 8, 2022 |
Arms and Interventions
| Group/Cohort | Intervention/treatment |
|---|---|
|
Hypertensive patients
Patients with SBP: 140-159; DBP: 90-99
|
Other: No interventions
No interventions - observational study
|
Outcome Measures
Primary Outcome Measures :
- Measurement of percentage change in diffusion parameters of the white matter [ Time Frame: At Enrollment; at 1 year Follow-up ]Fiber tracking by DTI MRI
Secondary Outcome Measures :
- Detection of cognitive decline by decrease of MoCA score [ Time Frame: At Enrollment; at 1 year Follow-up ]Cognitive tests
- Characterization of cardiac hypertensive organ damage progression [ Time Frame: At Enrollment; at 1 year Follow-up ]Echography
- Characterization of renal hypertensive organ damage progression [ Time Frame: At Enrollment; at 1 year Follow-up ]eGFR
- Characterization of Blood Pressure Variability [ Time Frame: At Enrollment; at 1 year Follow-up ]24h registration of systolic and diastolic blood pressure
Biospecimen Retention: Samples Without DNA
Blood and urine for biochemical analysis
Eligibility Criteria
| Ages Eligible for Study: | 40 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Subjects will be selected from patients attending the Department of AngioCardioNeurology of the IRCCS Neuromed, accordingly to the following inclusion/exclusion criteria. Approximately 176 subjects of both genders will be included in the study.
Criteria
Inclusion Criteria:
- age ≥ 40 and ≤ 70 years
- patients with moderate hypertension
- written informed consent
Exclusion Criteria:
- previous IMA, stroke or TIA
- arrhythmia or severe cardiac disease
- Diabetes or renal disease
- psychiatric disease
- neurological or neurodegenerative disease
- dementia
- assumption of drugs known to interfere with cognitive function
- inability to be subjected MRI analysis
- participation to other clinical trial, ongoing or terminated less than one month before enrolment in this study.
Contacts and Locations
Contacts
| Contact: Giuseppe Lembo, MD, PhD | +390865915225 | lembo@neuromed.it |
Locations
| Italy | |
| IRCCS Neuromed | Recruiting |
| Pozzilli, Isernia, Italy, 86077 | |
| Contact: Giuseppe Lembo, MD, PhD +39 0865.915225 lembo@neuromed.it | |
| Principal Investigator: Giuseppe Lembo, MD, PhD | |
| Sub-Investigator: Lorenzo Carnevale, MSc | |
Sponsors and Collaborators
Neuromed IRCCS
IRCCS Multimedica
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | June 10, 2019 | ||||
| First Posted Date | June 14, 2019 | ||||
| Last Update Posted Date | September 10, 2020 | ||||
| Actual Study Start Date | December 9, 2019 | ||||
| Estimated Primary Completion Date | December 8, 2022 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
Measurement of percentage change in diffusion parameters of the white matter [ Time Frame: At Enrollment; at 1 year Follow-up ] Fiber tracking by DTI MRI
|
||||
| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures |
|
||||
| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Novel Approaches of Advanced Neuroimaging Based on MRI Fiber Tracking to Detect Early Signs of Vascular Cognitive Impairment in Hypertensive Patients | ||||
| Official Title | Novel Approaches of Advanced Neuroimaging Based on MRI Fiber Tracking to Detect Early Signs of Vascular Cognitive Impairment in Hypertensive Patients | ||||
| Brief Summary | Hypertension is the major risk factor for vascular cognitive impairment (VCI). One of the main limitations in the clinical approach to VCI is that, by the time that it is manifested, it might be too late to reverse the neurodegenerative process. Thus, early identification of predictive signs of later dementia is demanding for management of hypertensive patients (HT).This aim claims for new methods that compute in a cloud all possible data sources coming from patients (brain imaging, cognitive profile, clinical data), to extract discriminative aggregate biomarkers. Thus, this study aims at: 1) characterizing the predictive potential of an aggregate biomarker for dementia in HT, based on brain imaging, clinical and cognitive assessment; 2) evaluating the impact of blood pressure variability, besides systolic/diastolic blood pressure, on the progression of the aggregate biomarker; 3) assessing whether specific classes of antihypertensive drugs differently affect the progression of the aggregate biomarker. In order to do this, this study proposes to evaluate advanced brain imaging and cognitive profile in a cohort of hypertensive patients, at baseline and after a 1 year follow up, to identify an innovative signature for the development of cognitive dysfunction in hypertension. In particular, the effects of blood pressure variability and of different classes of antihypertensive drugs will be evaluated. | ||||
| Detailed Description | Not Provided | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Case-Only Time Perspective: Prospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples Without DNA Description:
Blood and urine for biochemical analysis
|
||||
| Sampling Method | Probability Sample | ||||
| Study Population | Subjects will be selected from patients attending the Department of AngioCardioNeurology of the IRCCS Neuromed, accordingly to the following inclusion/exclusion criteria. Approximately 176 subjects of both genders will be included in the study. | ||||
| Condition | Hypertension | ||||
| Intervention | Other: No interventions
No interventions - observational study
|
||||
| Study Groups/Cohorts | Hypertensive patients
Patients with SBP: 140-159; DBP: 90-99
Intervention: Other: No interventions
|
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status | Recruiting | ||||
| Estimated Enrollment |
176 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | December 8, 2022 | ||||
| Estimated Primary Completion Date | December 8, 2022 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
||||
| Sex/Gender |
|
||||
| Ages | 40 Years to 70 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts |
|
||||
| Listed Location Countries | Italy | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03986957 | ||||
| Other Study ID Numbers | LMB07 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
|
||||
| IPD Sharing Statement |
|
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| Responsible Party | Giuseppe Lembo, Neuromed IRCCS | ||||
| Study Sponsor | Neuromed IRCCS | ||||
| Collaborators | IRCCS Multimedica | ||||
| Investigators | Not Provided | ||||
| PRS Account | Neuromed IRCCS | ||||
| Verification Date | September 2020 | ||||
