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

15 de mayo de 2026 actualizado por: 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.

Descripción general del estudio

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

50

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Rafael Mila, MD
  • Número de teléfono: 9 +59824871515
  • Correo electrónico: r1000a@gmail.com

Copia de seguridad de contactos de estudio

  • Nombre: Victor Dayan, MD, PhD
  • Número de teléfono: 9 +5989924871515
  • Correo electrónico: victordayan24@gmail.com

Ubicaciones de estudio

    • Montevideo Department
      • Montevideo, Montevideo Department, Uruguay, 11600
        • Hospital de Clínicas Dr. Manuel Quintela
        • Contacto:
          • Rafael Mila, MD
          • Número de teléfono: +59824875201
          • Correo electrónico: cencar@hc.edu.uy
        • Contacto:
          • Victor Dayan, MD, PhD
          • Número de teléfono: +59824875201
          • Correo electrónico: cencar@hc.edu.uy

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
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 therapy, cardiovascular risk factor optimization, or revascularization evaluation when clinically indicated.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Angina-Related Health Status Assessed by the Seattle Angina Questionnaire-7
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Health-Related Quality of Life Assessed by the EuroQol 5-Dimension 5-Level Visual Analog Scale
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

15 de mayo de 2026

Finalización primaria (Estimado)

30 de abril de 2029

Finalización del estudio (Estimado)

30 de abril de 2029

Fechas de registro del estudio

Enviado por primera vez

10 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

15 de mayo de 2026

Publicado por primera vez (Actual)

18 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

18 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

15 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • FMV_1_2025_1_186667 (Otro número de subvención/financiamiento: Agencia Nacional de Investigación e Innovación (ANII), Fondo María Viñas)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Descripción del plan IPD

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.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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