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Invasive Evaluation and Phenotype-Guided Treatment of ANOCA in Women (ANOCA-UY)

15. maj 2026 opdateret af: Rafael Mila, Hospital de Clínicas Dr. Manuel Quintela

Invasive Functional and Morphological Coronary Assessment Followed by Phenotype-Guided Multidisciplinary Treatment in Women With Angina and Non-Obstructive Coronary Arteries: A Prospective Single-Center Interventional Study

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Angina with non-obstructive coronary arteries (ANOCA) is a prevalent and frequently underdiagnosed clinical condition, particularly in women. Although obstructive epicardial coronary artery disease is absent, symptoms may be related to coronary microvascular dysfunction, epicardial or microvascular vasospasm, endothelial dysfunction, non-obstructive atherosclerotic plaque, myocardial bridging, or combined mechanisms. In routine clinical practice, many patients remain without a precise pathophysiological diagnosis after conventional angiography.

This study will evaluate a structured diagnostic and therapeutic pathway for women with ANOCA at a single academic cardiovascular center in Uruguay. Eligible participants will undergo an invasive coronary assessment performed during cardiac catheterization. The protocol will include angiographic confirmation of non-obstructive coronary arteries, invasive coronary physiology assessment, acetylcholine provocation testing for coronary vasomotor disorders, and optical coherence tomography for intracoronary morphological assessment.

The invasive findings will be integrated to classify participants according to their predominant functional and/or morphological phenotype. Potential phenotypes include coronary microvascular dysfunction, epicardial vasospasm, microvascular spasm, endothelial dysfunction, functional epicardial disease, non-obstructive plaque-related abnormalities, combined mechanisms, or normal invasive coronary physiology.

After phenotyping, participants will receive an individualized treatment plan according to the identified mechanism. This may include targeted pharmacological therapy, cardiovascular risk factor optimization, adapted cardiovascular rehabilitation, and structured psycho-emotional support when clinically indicated. The therapeutic strategy will be determined by the treating clinical team according to the study protocol and current evidence-based recommendations.

Participants will be followed for 12 months after the invasive assessment. Follow-up visits will assess angina symptoms, health-related quality of life, functional capacity, treatment adherence, adverse events, and cardiovascular outcomes. The study aims to generate local evidence on the feasibility and clinical utility of a phenotype-guided approach for women with ANOCA and to support the development of a multidisciplinary reference pathway for this condition in Uruguay.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

50

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Uruguay
    • Montevideo Department
      • Montevideo, Montevideo Department, Uruguay, 11600
        • Hospital de Clínicas Dr. Manuel Quintela
        • Kontakt:
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • 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.
  • Written informed consent.

Exclusion Criteria:

  • 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.
  • Inability to complete the diagnostic or therapeutic study protocol.
  • Participation in another clinical study that could interfere with the present protocol.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Phenotype-Guided Diagnostic and Therapeutic Strategy
Participants will undergo a standardized invasive coronary assessment to identify functional and morphological mechanisms of angina with non-obstructive coronary arteries. Based on the identified phenotype, participants will receive individualized treatment including targeted pharmacological therapy, adapted cardiovascular rehabilitation, and psycho-emotional support when clinically indicated.
Procedure: Invasive Coronary Functional and Morphological Assessment
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.
Medicin: Pharmacological treatment will be individualized according to the invasive coronary phenotype identified. Treatment may include antianginal therapy, vasodilator therapy, endothelial function-targeted
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Angina-Related Health Status Assessed by the Seattle Angina Questionnaire-7
Tidsramme: Baseline to 12 months
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.
Baseline to 12 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Health-Related Quality of Life Assessed by the EuroQol 5-Dimension 5-Level Visual Analog Scale
Tidsramme: Baseline to 12 months
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.
Baseline to 12 months
Change in Functional Capacity
Tidsramme: Baseline to 12 months
Change in functional capacity assessed by six-minute walk test distance or exercise testing parameters, according to the local study protocol.
Baseline to 12 months
Prevalence of Invasive Coronary Functional Phenotypes
Tidsramme: At index invasive coronary procedure
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.
At index invasive coronary procedure
Prevalence of Coronary Morphological Abnormalities Assessed by Optical Coherence Tomography
Tidsramme: At index invasive coronary procedure
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.
At index invasive coronary procedure
Change in Perceived Stress Assessed by the Perceived Stress Scale-4
Tidsramme: Baseline to 6 and 12 months
Change in Perceived Stress Scale-4 score from baseline to 6-month and 12-month follow-up. The Perceived Stress Scale-4 is a 4-item patient-reported measure of perceived stress during the previous month. Total scores range from 0 to 16, with higher scores indicating greater perceived stress and a worse outcome.
Baseline to 6 and 12 months
Medication Adherence Assessed by the Modified Morisky-Green-Levine Questionnaire
Tidsramme: 1, 6, and 12 months
Medication adherence will be assessed using the modified Morisky-Green-Levine questionnaire at 1, 6, and 12 months. The modified Morisky-Green-Levine questionnaire is a patient-reported measure of medication adherence. Scores range from 0 to 4, with higher scores indicating better medication adherence.
1, 6, and 12 months
Major Adverse Cardiovascular Events
Tidsramme: Baseline to 12 months
Composite of death, myocardial infarction, hospitalization for cardiovascular causes, or coronary revascularization during follow-up.
Baseline to 12 months
Adherence to Cardiovascular Rehabilitation Assessed by Session Completion Rate
Tidsramme: During the 12-week cardiovascular rehabilitation program.
Adherence to cardiovascular rehabilitation will be assessed at 1, 6, and 12 months as the percentage of prescribed rehabilitation sessions completed. Higher percentages indicate better adherence. Adherence will be defined as completion of at least 75% of prescribed sessions.
During the 12-week cardiovascular rehabilitation program.
Adherence to Psycho-Emotional Support Assessed by Session Completion Rate
Tidsramme: 1, 6, and 12 months
Adherence to psycho-emotional support will be assessed at 1, 6, and 12 months as the percentage of prescribed sessions completed among participants for whom this intervention is clinically indicated. Higher percentages indicate better adherence. Adherence will be defined as completion of at least 75% of prescribed sessions.
1, 6, and 12 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Hospital de Clínicas Dr. Manuel Quintela

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

15. maj 2026

Primær færdiggørelse (Anslået)

30. april 2029

Studieafslutning (Anslået)

30. april 2029

Datoer for studieregistrering

Først indsendt

10. maj 2026

Først indsendt, der opfyldte QC-kriterier

15. maj 2026

Først opslået (Faktiske)

18. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • FMV_1_2025_1_186667 (Andet bevillings-/finansieringsnummer: Agencia Nacional de Investigación e Innovación (ANII), Fondo María Viñas)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

IPD-planbeskrivelse

The individual participant data sharing plan is currently undecided and will depend on institutional policies, ethics committee requirements, participant consent, and applicable data protection regulations.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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