NCT07563725

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
43mo left

Started Jun 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 4, 2026

Completed
28 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2029

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

3.5 years

First QC Date

April 22, 2026

Last Update Submit

April 29, 2026

Conditions

Keywords

microcirculationLaser Speckle Contrast Imagingvascular aging

Outcome Measures

Primary Outcomes (1)

  • Systemic (cutaneous) microcirculatory reactivity.

    To analyze structural and functional changes in the microcirculation in different ages groups, with emphasis on microvascular endothelial senescence.

    up to 20 minutes

Secondary Outcomes (1)

  • Muscle Strength

    up to 10 minutes

Study Arms (2)

elderly (60-80 years)

Evaluation of systemic microcirculation

Diagnostic Test: Laser Speckle Contrast ImagingDiagnostic Test: Handgrip Dynamometry (Muscle Strength)Diagnostic Test: Sit-to-Stand Test (5-Times Sit-to-Stand - 5STS)Diagnostic Test: Single-Leg Balance TestDiagnostic Test: Assessment of Global Cognitive Function

very elderly (>80)

Evaluation of systemic microcirculation

Diagnostic Test: Laser Speckle Contrast ImagingDiagnostic Test: Handgrip Dynamometry (Muscle Strength)Diagnostic Test: Sit-to-Stand Test (5-Times Sit-to-Stand - 5STS)Diagnostic Test: Single-Leg Balance TestDiagnostic Test: Assessment of Global Cognitive Function

Interventions

Investigation of Systemic Endothelial Microvascular Function

elderly (60-80 years)very elderly (>80)

Serving as a marker of systemic muscle strength and sarcopenia.

elderly (60-80 years)very elderly (>80)

This test will assess the strength and power of the lower limbs.

elderly (60-80 years)very elderly (>80)

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.

elderly (60-80 years)very elderly (>80)

Overall cognitive function will be assessed using the Mini-Mental State Examination.

elderly (60-80 years)very elderly (>80)

Eligibility Criteria

Age60 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eduardo Tibiriçá

Rio de Janeiro, 22240006, Brazil

Location

MeSH Terms

Interventions

Laser Speckle Contrast ImagingMuscle Strength

Intervention Hierarchy (Ancestors)

Optical ImagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesPhysical ExaminationMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Eduardo Tibirica, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Researcher

Study Record Dates

First Submitted

April 22, 2026

First Posted

May 4, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2029

Last Updated

May 4, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations