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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-65
SponsorNational Institute of Cardiology, Laranjeiras, Brazil

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-65 years

Anginal chest pain

Disqualifiers

Malignant neoplasms

Autoimmune diseases

Acute systemic diseases

Pregnancy or lactation

Trial population

Patients from a terciary cardiology hospital.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Investigation of Systemic Endothelial Microvascular Function

    Procedure/Surgery

    Investigation of Systemic Endothelial Microvascular Function

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: ANOCA1 intervention
Group B: CONTROL1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

Evaluation of endothelium-independent skin microvascular reactivity.

Evaluation of systemic microvascular reactivity induced by endothelium-independent agent (sodium nitroprusside). 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.

Time frame
Microvascular reactivity will be evaluated 20-minute rest in the supine position in a temperature-controlled room.
2

Evaluation of endothelium-dependent skin microvascular reactivity.

Evaluation of systemic microvascular reactivity induced by postocclusive reactive hyperemia. Microvascular reactivity will be evaluated using a non-invasive and operator -independent methodology, named laser speckle contrast imaging. Cutaneous microvascular flow will be measured in arbitrary perfusion units, divided by mean arterial pressure, to yield cutaneous vascular conductance.

Time frame
Microvascular reactivity will be evaluated 20-minute rest in the supine position in a temperature-controlled room.
3

Evaluation of sublingual microcirculation.

Sublingual microcirculatory density and perfusion will be assessed using a handheld camera based on incident dark-field (IDF) imaging.

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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