Invasive Evaluation and Phenotype-Guided Treatment of ANOCA in Women

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age35-75
SponsorHospital de Clínicas Dr. Manuel Quintela

About this trial

This prospective single-center interventional study will include women with angina and non-obstructive coronary arteries. Participants will undergo a standardized invasive coronary assessment combining coronary physiology, acetylcholine provocation testing, and optical coherence tomography. The diagnostic protocol will identify functional and morphological mechanisms of angina, including microvascular dysfunction, epicardial vasospasm, microvascular spasm, endothelial dysfunction, functional epicardial disease, combined mechanisms, or normal coronary physiology.

Based on the identified phenotype, participants will receive individualized multidisciplinary treatment, including targeted pharmacological therapy, adapted cardiovascular rehabilitation, and psycho-emotional support when indicated. Clinical follow-up will be performed at 1, 6, and 12 months to assess angina symptoms, quality of life, functional capacity, adherence to treatment, and cardiovascular events.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female participants aged 35 to 75 years.

Symptoms compatible with stable angina or suspected myocardial ischemia.

Non-obstructive coronary arteries, defined as absence of angiographic stenosis greater than or equal to 50%.

Ability to undergo invasive coronary assessment and clinical follow-up.

Disqualifiers

Significant structural heart disease.

Severe left ventricular systolic dysfunction, defined as left ventricular ejection fraction <40%.

Clinically relevant contraindication to adenosine or acetylcholine, including severe asthma, untreated high-grade atrioventricular block, or known hypersensitivity.

Active oncological disease or life expectancy less than 12 months.

Trial design

Design model

Single group

Treatments tested in this trial

  • Invasive Coronary Functional and Morphological Assessment

    Procedure/Surgery

    Participants will undergo invasive coronary assessment including coronary physiology measurements, acetylcholine provocation testing, and optical coherence tomography to identify functional and morphological mechanisms of angina with non-obstructive coronary arteries.

  • Pharmacological treatment will be individualized according to the invasive coronary phenotype identified. Treatment may include antianginal therapy, vasodilator therapy, endothelial function-targeted

    Drug

    Pharmacological treatment will be individualized according to the invasive coronary phenotype identified. Treatment may include antianginal therapy, vasodilator therapy, endothelial function-targeted therapy, cardiovascular risk factor optimization, or revascularization evaluation when clinically indicated.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Phenotype-Guided Diagnostic and Therapeutic StrategyExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Change in Angina-Related Health Status Assessed by the Seattle Angina Questionnaire-7

Change in Seattle Angina Questionnaire-7 score from baseline to 12-month follow-up after invasive coronary phenotyping and phenotype-guided multidisciplinary treatment. The Seattle Angina Questionnaire-7 is a 7-item patient-reported outcome measure assessing angina-related health status. Scores range from 0 to 100, with higher scores indicating better angina-related health status and fewer symptoms.

Time frame
Baseline to 12 months

Secondary outcomes

1

Change in Health-Related Quality of Life Assessed by the EuroQol 5-Dimension 5-Level Visual Analog Scale

Change in EuroQol 5-Dimension 5-Level Visual Analog Scale score from baseline to 12-month follow-up. The EuroQol 5-Dimension 5-Level Visual Analog Scale is a patient-reported measure of overall health status. Scores range from 0 to 100, with higher scores indicating better self-reported health.

Time frame
Baseline to 12 months
2

Change in Functional Capacity

Change in functional capacity assessed by six-minute walk test distance or exercise testing parameters, according to the local study protocol.

Time frame
Baseline to 12 months
3

Prevalence of Invasive Coronary Functional Phenotypes

Proportion of participants classified as having coronary microvascular dysfunction, epicardial vasospasm, microvascular spasm, endothelial dysfunction, functional epicardial disease, combined mechanisms, or normal invasive coronary physiology.

Time frame
At index invasive coronary procedure
4

Prevalence of Coronary Morphological Abnormalities Assessed by Optical Coherence Tomography

Proportion of participants with non-obstructive atherosclerotic plaque, plaque rupture, plaque erosion, thin-cap fibroatheroma, macrophage accumulation, positive remodeling, myocardial bridging, spontaneous coronary artery dissection, or other optical coherence tomography findings.

Time frame
At index invasive coronary procedure

Other outcomes

Sponsors and contacts

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