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Not yet recruiting NCT07558018

Evaluation of the Systemic Microcirculation as a Surrogate for Coronary Microcirculation in Women With ANOCA

— Observational Angina, Microvascular

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Investigation of Systemic Endothelial Microvascular Function.
Who it may be relevant to
Registry conditions: Angina, Microvascular. Basic parameters: 18 years — 65 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Evaluation of the Systemic Microcirculation as a Surrogate for Coronary Microcirculation in Women With ANOCA: Insights Into Pathophysiology and Diagnosis Using Noninvasive, Innovative Techniques (NOCAWT)

Overview

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.

Detailed description

The study will involve women aged 18 to 65 years, with stable anginal chest pain and no coronary artery disease (ANOCA) (absence of coronary plaque in coronary angiography or computed tomography coronary angiography - CCTA), recruited at the National Institute of Cardiology (INC). The upper age limit was established to limit the influence of vascular senescence on the results.

Interventions

  • Procedure Investigation of Systemic Endothelial Microvascular Function
    Investigation of Systemic Endothelial Microvascular Function

Primary outcome measures

  • Evaluation of endothelium-dependent skin microvascular reactivity. [Time frame: Microvascular reactivity will be evaluated 20-minute rest in the supine position in a temperature-controlled room.]
Secondary outcome measures (3)
  • Evaluation of endothelium-independent skin microvascular reactivity. [Time frame: Microvascular reactivity will be evaluated 20-minute rest in the supine position in a temperature-controlled room.]
  • Evaluation of endothelium-dependent skin microvascular reactivity. [Time frame: Microvascular reactivity will be evaluated 20-minute rest in the supine position in a temperature-controlled room.]
  • Evaluation of sublingual microcirculation. [Time frame: Microvascular reactivity will be evaluated 20-minute rest in the supine position in a temperature-controlled room.]

Eligibility criteria

Inclusion criteria

  • Age 18-65 years
  • Anginal chest pain

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07558018 · NOCoronaryArtery Women Testing

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗