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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Eduardo Tibirica, MD, PhD
  • Phone Number: +55-21-99914-6075
  • Email: etibi@uol.com.br

Study Locations

  • Brazil
      • Rio de Janeiro, Brazil, 22240006
        • Eduardo Tibiriçá

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
elderly (60-80 years)
Evaluation of systemic microcirculation
Diagnostic test: Laser Speckle Contrast Imaging
Investigation of Systemic Endothelial Microvascular Function
Diagnostic test: Handgrip Dynamometry (Muscle Strength)
Serving as a marker of systemic muscle strength and sarcopenia.
Diagnostic test: Sit-to-Stand Test (5-Times Sit-to-Stand - 5STS)
This test will assess the strength and power of the lower limbs.
Diagnostic test: Single-Leg Balance Test
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.
Diagnostic test: Assessment of Global Cognitive Function
Overall cognitive function will be assessed using the Mini-Mental State Examination.
very elderly (>80)
Evaluation of systemic microcirculation
Diagnostic test: Laser Speckle Contrast Imaging
Investigation of Systemic Endothelial Microvascular Function
Diagnostic test: Handgrip Dynamometry (Muscle Strength)
Serving as a marker of systemic muscle strength and sarcopenia.
Diagnostic test: Sit-to-Stand Test (5-Times Sit-to-Stand - 5STS)
This test will assess the strength and power of the lower limbs.
Diagnostic test: Single-Leg Balance Test
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.
Diagnostic test: Assessment of Global Cognitive Function
Overall cognitive function will be assessed using the Mini-Mental State Examination.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Institute of Cardiology, Laranjeiras, Brazil

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 22, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 4, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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