- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07563725
Vascular Aging and Microcirculation: Physiological Aspects of Vascular Aging in the Elderly Population (VAMP-Aging) (VAMP-Aging)
April 29, 2026 updated by: Eduardo Tibirica, MD, PhD, National Institute of Cardiology, Laranjeiras, Brazil
Rising life expectancy worldwide challenges public health due to increased cardiovascular disease linked to vascular aging, where microvascular dysfunction serves as an early indicator of system-wide inflammation, or "inflammaging".
The proposed study aims to validate non-invasive, high-resolution techniques, such as Laser Speckle Contrast Imaging, to identify early endothelial senescence biomarkers and map their correlation with metabolic, inflammatory, and anthropometric profiles to advance personalized, preventive translational medicine.
Study Overview
Status
Not yet recruiting
Conditions
Detailed Description
An observational, cross-sectional study will be conducted, including volunteers aged ≥ 60 years, divided into two groups: elderly (60-80 years) and very elderly (>80).
Young volunteers aged between 20 and 40 years, already participants in previous studies, whose demographic and microcirculation data are in the research laboratory's database, will be included as controls.
Data from the control group will be obtained from an institutional database, respecting confidentiality and anonymization, in accordance with current ethical standards.
Study Type
Observational
Enrollment (Estimated)
62
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Eduardo Tibirica, MD, PhD
- Phone Number: +55-21-99914-6075
- Email: etibi@uol.com.br
Study Locations
-
-
-
Rio de Janeiro, Brazil, 22240006
- Eduardo Tibiriçá
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
An observational, cross-sectional study will be conducted, including volunteers aged ≥ 60 years, divided into two groups: elderly (60-80 years) and very elderly (>80).
Young volunteers aged between 20 and 40 years, already participants in previous studies, whose demographic and microcirculation data are in the research laboratory's database, will be included as controls.
Data from the control group will be obtained from an institutional database, respecting confidentiality and anonymization, in accordance with current ethical standards.
Description
Inclusion Criteria:
- Absence of symptoms and history of cardiovascular and cerebrovascular diseases.
- Baseline blood pressure levels within the normal range (< 140/90 mmHg, according to WHO criteria) and absence of use of antihypertensive medications.
Exclusion Criteria:
- Diabetes Mellitus: Fasting blood glucose ≥ 126 mg/dL or use of hypoglycemic agents.
- Smoking: Active or quit less than 5 years ago.
- Inflammatory Diseases: Autoimmune diseases, active neoplasms, or acute infectious processes.
- Surgery or trauma in the last 60 days.
- Renal Dysfunction: Chronic renal failure (estimated by eGFR < 60 mL/min/1.73m²).
- Medication Use: Chronic use of corticosteroids, immunosuppressants, or drugs with direct action on vascular reactivity (e.g., continuous use of nitrates).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
elderly (60-80 years)
Evaluation of systemic microcirculation
|
Investigation of Systemic Endothelial Microvascular Function
Serving as a marker of systemic muscle strength and sarcopenia.
This test will assess the strength and power of the lower limbs.
Failure to maintain the position (to stand on one leg) for at least 10 seconds will be correlated as a marker of frailty and risk of falls.
Overall cognitive function will be assessed using the Mini-Mental State Examination.
|
|
very elderly (>80)
Evaluation of systemic microcirculation
|
Investigation of Systemic Endothelial Microvascular Function
Serving as a marker of systemic muscle strength and sarcopenia.
This test will assess the strength and power of the lower limbs.
Failure to maintain the position (to stand on one leg) for at least 10 seconds will be correlated as a marker of frailty and risk of falls.
Overall cognitive function will be assessed using the Mini-Mental State Examination.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Systemic (cutaneous) microcirculatory reactivity.
Time Frame: up to 20 minutes
|
To analyze structural and functional changes in the microcirculation in different ages groups, with emphasis on microvascular endothelial senescence.
|
up to 20 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscle Strength
Time Frame: up to 10 minutes
|
Handgrip Dynamometry Maximum isometric strength will be assessed using a manual hydraulic dynamometer.
|
up to 10 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
June 1, 2026
Primary Completion (Estimated)
December 1, 2029
Study Completion (Estimated)
December 1, 2029
Study Registration Dates
First Submitted
April 22, 2026
First Submitted That Met QC Criteria
April 29, 2026
First Posted (Actual)
May 4, 2026
Study Record Updates
Last Update Posted (Actual)
May 4, 2026
Last Update Submitted That Met QC Criteria
April 29, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VAMP-Aging
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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