NCT07558018

Brief Summary

The primary objective of this project is to validate a multi-modal systemic microvascular phenotyping platform-combining Laser Speckle Contrast Imaging (LSCI) and Sublingual Handheld Videomicroscopy (IDF imaging)-as a non-invasive surrogate for coronary microvascular function in women with ANOCA (Angina with Non-Obstructive Coronary Arteries). We aim to demonstrate that systemic microvascular signatures (microvascular reactivity and density) can predict coronary endotypes with high accuracy, potentially reducing the need for invasive diagnostics.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
41mo left

Started Aug 2026

Typical duration for all trials

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
8 days until next milestone

First Posted

Study publicly available on registry

April 30, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2026

Expected
3.3 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 5, 2026

Status Verified

May 1, 2026

Enrollment Period

3.3 years

First QC Date

April 22, 2026

Last Update Submit

May 2, 2026

Conditions

Angina, Microvascular

Keywords

microcirculationLaser Speckle Contrast ImagingSublingual videomicroscopy

Outcome Measures

Primary Outcomes (1)

  • Evaluation of endothelium-dependent skin microvascular reactivity.

    Evaluation of systemic microvascular reactivity induced by endothelium-dependent agent (acetylcholine). Microvascular reactivity will be evaluated using a non-invasive and operator -independent methodology, named laser speckle contrast imaging, coupled with skin iontophoresis of vasodilator agents. Cutaneous microvascular flow will be measured in arbitrary perfusion units, divided by mean arterial pressure, to yield cutaneous vascular conductance.

    Microvascular reactivity will be evaluated 20-minute rest in the supine position in a temperature-controlled room.

Secondary Outcomes (3)

  • Evaluation of endothelium-independent skin microvascular reactivity.

    Microvascular reactivity will be evaluated 20-minute rest in the supine position in a temperature-controlled room.

  • Evaluation of endothelium-dependent skin microvascular reactivity.

    Microvascular reactivity will be evaluated 20-minute rest in the supine position in a temperature-controlled room.

  • Evaluation of sublingual microcirculation.

    Microvascular reactivity will be evaluated 20-minute rest in the supine position in a temperature-controlled room.

Study Arms (2)

ANOCA

Symptomatic Group (ANOCA): n = 40 patients with stable angina and non-obstructive coronary arteries.

Procedure: Investigation of Systemic Endothelial Microvascular Function

CONTROL

Control Group: n = 20 age-matched women without chest pain and without CAD.

Procedure: Investigation of Systemic Endothelial Microvascular Function

Interventions

Investigation of Systemic Endothelial Microvascular FunctionPROCEDURE

Investigation of Systemic Endothelial Microvascular Function

Also known as: Myocardial Perfusion Imaging, Sublingual videomicroscopy, Invasive coronary flow determination, Cutaneous Laser Speckle Contrast Imaging
ANOCACONTROL

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen presenting with stable anginal chest pain and no coronary artery disease (ANOCA) (absence of coronary plaque in coronary angiography or computed tomography coronary angiography).
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients from a terciary cardiology hospital.

You may qualify if:

  • Age 18-65 years
  • Anginal chest pain

You may not qualify if:

  • Malignant neoplasms
  • Autoimmune diseases
  • Acute systemic diseases
  • Pregnancy or lactation
  • Iodine allergy
  • CAD on invasive coronary angiography or coronary computed tomography angiography (CCTA)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Microvascular Angina

Condition Hierarchy (Ancestors)

Angina PectorisMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Central Study Contacts

Eduardo Tibirica, MD, PhD

CONTACT

+55-21-99914-6075etibi@uol.com.br

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

April 30, 2026

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2029

Last Updated

May 5, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share