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

15. mai 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Antatt)

50

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Uruguay
    • Montevideo Department
      • Montevideo, Montevideo Department, Uruguay, 11600
        • Hospital de Clínicas Dr. Manuel Quintela
        • Ta kontakt med:
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Fremgangsmåte: 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.
Legemiddel: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Hospital de Clínicas Dr. Manuel Quintela

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

15. mai 2026

Primær fullføring (Antatt)

30. april 2029

Studiet fullført (Antatt)

30. april 2029

Datoer for studieregistrering

Først innsendt

10. mai 2026

Først innsendt som oppfylte QC-kriteriene

15. mai 2026

Først lagt ut (Faktiske)

18. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

18. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

15. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • FMV_1_2025_1_186667 (Annet stipend/finansieringsnummer: Agencia Nacional de Investigación e Innovación (ANII), Fondo María Viñas)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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