Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Exercise Metrics and Perfusion Indices in CoRonary Microvascular Dysfunction: A Multimodal Correlative Study in ANOCA and HFpEF Patients (EMPIRE-Trial)

8 de noviembre de 2026 actualizado por: Muhammed Gerçek, Heart and Diabetes Center North-Rhine Westfalia

Coronary microvascular dysfunction (CMD) has emerged as a key pathophysiological mechanism underlying symptoms in patients with angina and/or exertional dyspnea, particu-larly in the absence of obstructive coronary artery disease. CMD is prevalent in both ANOCA (Angina with Non-Obstructive Coronary Arteries) and HFpEF (Heart Failure with preserved Ejection Fraction), and is associated with poor clinical outcomes, including hospitalization and mortality. However, CMD remains frequently underdiagnosed due to the lack of simple, non-invasive diagnostic tools and the complexity of invasive assessment techniques such as the Index of Microcirculatory Resistance (IMR) and corrected Fractional Flow Reserve (cFR).

Cardiopulmonary exercise testing (CPET) and echocardiography are widely accessible and routinely used modalities that may reflect hemodynamic consequences of CMD. CPET pro-vides a comprehensive assessment of cardiopulmonary performance and exercise tolerance, while echocardiography allows for non-invasive evaluation of diastolic function, left atrial pressure, and right heart-pulmonary interactions. Nevertheless, the extent to which these measures correlate with invasive CMD parameters has not been systematically studied.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

120

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: Muhammed Gercek
  • Número de teléfono: 0049571971258
  • Correo electrónico: mugercek@hdz-nrw.de

Ubicaciones de estudio

  • Alemania
    • North Rhine-Westphalia
      • Bad Oeynhausen, North Rhine-Westphalia, Alemania, 32545
        • Reclutamiento
        • Heart and Diabetes Center NRW
        • Contacto:
          • Muhammed Gerçek, MD
          • Número de teléfono: +495731971258
          • Correo electrónico: mugercek@hdz-nrw.de
        • Contacto:

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

  • Niño
  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Age ≥ 18 years
  • Absence of obstructive coronary artery disease (stenosis <50% or FFR >0.80)
  • No sign of HFpEF or microvascular dysfunction history of angina, dyspnea, or heart failure
  • Undergoing CPET and echocardiography
  • No structural or ischemic heart disease
  • Written informed consent

Exclusion Criteria:

  • • Significant structural heart disease (e.g., severe valvular disease)

    • Severe pulmonary disease (e.g., COPD GOLD III-IV, interstitial lung disease)
    • Acute coronary syndrome within the past 3 months
    • Inability to perform exercise testing

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: Diagnóstico
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Otro: patients with ANOCA or HFpEF

Patients with angina and/or exertional dyspnea without obstructive coronary artery disease (ANOCA or HFpEF phenotype).
Prueba de diagnóstico: All participants will undergo cardiopulmonary exercise testing (CPET), transthoracic echocardiography, and invasive coronary angiography with functional microvascular assessment (IMR, cFR, RFR). No in

This is a prospective, observational, controlled cohort study including patients with suspected coronary microvascular dysfunction (CMD) presenting as ANOCA or HFpEF and asymptomatic control individuals without evidence of coronary or myocardial disease, microvascular dysfunction or heart failure with preserved ejection fraction. All participants will undergo cardiopulmonary exercise testing (CPET), transthoracic echocardiography, and invasive coronary angiography with functional microvascular assessment (IMR, cFR, RFR). No interventions outside of standard clinical care will be performed. Comparative analyses will focus on correlations between CPET parameters, echocardiographic markers, and invasive microvascular indices, as well as differences between symptomatic patients and controls.

The study will include:

  • Patients with angina and/or exertional dyspnea without obstructive coronary artery disease (ANOCA or HFpEF phenotype).
  • Control individuals without evidence of coronary or my
Otro: control participants

Control individuals without evidence of coronary or myocardial disease, microvascular dysfunction or heart failure with preserved ejection fraction
Prueba de diagnóstico: All participants will undergo cardiopulmonary exercise testing (CPET), transthoracic echocardiography, and invasive coronary angiography with functional microvascular assessment (IMR, cFR, RFR). No in

This is a prospective, observational, controlled cohort study including patients with suspected coronary microvascular dysfunction (CMD) presenting as ANOCA or HFpEF and asymptomatic control individuals without evidence of coronary or myocardial disease, microvascular dysfunction or heart failure with preserved ejection fraction. All participants will undergo cardiopulmonary exercise testing (CPET), transthoracic echocardiography, and invasive coronary angiography with functional microvascular assessment (IMR, cFR, RFR). No interventions outside of standard clinical care will be performed. Comparative analyses will focus on correlations between CPET parameters, echocardiographic markers, and invasive microvascular indices, as well as differences between symptomatic patients and controls.

The study will include:

  • Patients with angina and/or exertional dyspnea without obstructive coronary artery disease (ANOCA or HFpEF phenotype).
  • Control individuals without evidence of coronary or my

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Correlation Between Peak Oxygen Uptake (VO₂peak) and Index of Microcirculatory Resistance (IMR)
Periodo de tiempo: Baseline (during the initial diagnostic assessment)

Correlation between peak oxygen uptake (VO₂peak), measured by cardiopulmonary exercise testing (CPET), and the index of microcirculatory resistance (IMR), measured during invasive coronary angiography. The association will be quantified using Pearson's or Spearman's correlation coefficient, as appropriate. The correlation coefficient is dimensionless.
Baseline (during the initial diagnostic assessment)
Correlation Between Peak Oxygen Uptake (VO₂peak) and CFR
Periodo de tiempo: Baseline (during the initial diagnostic assessment)

Correlation between peak oxygen uptake (VO₂peak), measured by cardiopulmonary exercise testing (CPET), and CFR, assessed during invasive coronary angiography. The association will be quantified using Pearson's or Spearman's correlation coefficient, as appropriate. The correlation coefficient is dimensionless.
Baseline (during the initial diagnostic assessment)
Correlation Between Peak Oxygen Uptake (VO₂peak) and Resting Full-Cycle Ratio (RFR)
Periodo de tiempo: Baseline (during the initial diagnostic assessment)

Correlation between peak oxygen uptake (VO₂peak), measured by cardiopulmonary exercise testing (CPET), and resting full-cycle ratio (RFR), assessed during invasive coronary angiography. The association will be quantified using Pearson's or Spearman's correlation coefficient, as appropriate. The correlation coefficient is dimensionless.
Baseline (during the initial diagnostic assessment)
Correlation Between VE/VCO₂ Slope and Index of Microcirculatory Resistance (IMR)
Periodo de tiempo: Baseline (during the initial diagnostic assessment)

Correlation between the ventilatory efficiency parameter VE/VCO₂ slope, measured by cardiopulmonary exercise testing (CPET), and the index of microcirculatory resistance (IMR), assessed during invasive coronary angiography. The association will be quantified using Pearson's or Spearman's correlation coefficient, as appropriate. The correlation coefficient is dimensionless.
Baseline (during the initial diagnostic assessment)
Correlation Between VE/VCO₂ Slope and CFR
Periodo de tiempo: Baseline (during the initial diagnostic assessment)

Correlation between the ventilatory efficiency parameter VE/VCO₂ slope, measured by cardiopulmonary exercise testing (CPET), and CFR, assessed during invasive coronary angiography. The association will be quantified using Pearson's or Spearman's correlation coefficient, as appropriate. The correlation coefficient is dimensionless.
Baseline (during the initial diagnostic assessment)
Correlation Between VE/VCO₂ Slope and Resting Full-Cycle Ratio (RFR)
Periodo de tiempo: Baseline (during the initial diagnostic assessment)

Correlation between the ventilatory efficiency parameter VE/VCO₂ slope, measured by cardiopulmonary exercise testing (CPET), and resting full-cycle ratio (RFR), assessed during invasive coronary angiography. The association will be quantified using Pearson's or Spearman's correlation coefficient, as appropriate. The correlation coefficient is dimensionless.
Baseline (during the initial diagnostic assessment)
Correlation Between Oxygen Pulse and Index of Microcirculatory Resistance (IMR)
Periodo de tiempo: Baseline (during the initial diagnostic assessment)

Correlation between oxygen pulse (O₂ pulse), measured by cardiopulmonary exercise testing (CPET), and the index of microcirculatory resistance (IMR), assessed during invasive coronary angiography. The association will be quantified using Pearson's or Spearman's correlation coefficient, as appropriate. The correlation coefficient is dimensionless.
Baseline (during the initial diagnostic assessment)
Correlation Between Oxygen Pulse and CFR
Periodo de tiempo: Baseline (during the initial diagnostic assessment)

Correlation between oxygen pulse (O₂ pulse), measured by cardiopulmonary exercise testing (CPET), and cFR, assessed during invasive coronary angiography. The association will be quantified using Pearson's or Spearman's correlation coefficient, as appropriate. The correlation coefficient is dimensionless.
Baseline (during the initial diagnostic assessment)
Correlation Between Oxygen Pulse and Resting Full-Cycle Ratio (RFR)
Periodo de tiempo: Baseline (during the initial diagnostic assessment)

Correlation between oxygen pulse (O₂ pulse), measured by cardiopulmonary exercise testing (CPET), and resting full-cycle ratio (RFR), assessed during invasive coronary angiography. The association will be quantified using Pearson's or Spearman's correlation coefficient, as appropriate. The correlation coefficient is dimensionless.
Baseline (during the initial diagnostic assessment)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Correlation Between E/e' Ratio and Index of Microcirculatory Resistance (IMR)
Periodo de tiempo: Baseline (during the initial diagnostic assessment)

Correlation between the echocardiographically assessed E/e' ratio, a marker of left ventricular filling pressure, and the index of microcirculatory resistance (IMR), measured during invasive coronary angiography. The association will be quantified using Pearson's or Spearman's correlation coefficient, as appropriate. The correlation coefficient is dimensionless.
Baseline (during the initial diagnostic assessment)
Correlation Between E/e' Ratio and cFR
Periodo de tiempo: Baseline (during the initial diagnostic assessment)

Correlation between the echocardiographically assessed E/e' ratio and cFR, measured during invasive coronary angiography. The association will be quantified using Pearson's or Spearman's correlation coefficient, as appropriate. The correlation coefficient is dimensionless.
Baseline (during the initial diagnostic assessment)
Correlation Between E/e' Ratio and Resting Full-Cycle Ratio (RFR)
Periodo de tiempo: Baseline (during the initial diagnostic assessment)

Correlation between the echocardiographically assessed E/e' ratio and resting full-cycle ratio (RFR), measured during invasive coronary angiography. The association will be quantified using Pearson's or Spearman's correlation coefficient, as appropriate. The correlation coefficient is dimensionless.
Baseline (during the initial diagnostic assessment)
Correlation Between Left Atrial Volume Index (LAVI) and Index of Microcirculatory Resistance (IMR)
Periodo de tiempo: Baseline (during the initial diagnostic assessment)

Correlation between left atrial volume index (LAVI), assessed by transthoracic echocardiography and expressed in mL/m², and the index of microcirculatory resistance (IMR), measured during invasive coronary angiography. The association will be quantified using Pearson's or Spearman's correlation coefficient, as appropriate. The correlation coefficient is dimensionless.
Baseline (during the initial diagnostic assessment)
Correlation Between Left Atrial Volume Index (LAVI) and cFR
Periodo de tiempo: Baseline (during the initial diagnostic assessment)

Correlation between left atrial volume index (LAVI), assessed by transthoracic echocardiography and expressed in mL/m², and cFR, measured during invasive coronary angiography. The association will be quantified using Pearson's or Spearman's correlation coefficient, as appropriate. The correlation coefficient is dimensionless.
Baseline (during the initial diagnostic assessment)
Correlation Between Left Atrial Volume Index (LAVI) and Resting Full-Cycle Ratio (RFR)
Periodo de tiempo: Baseline (during the initial diagnostic assessment)

Correlation between left atrial volume index (LAVI), assessed by transthoracic echocardiography and expressed in mL/m², and resting full-cycle ratio (RFR), measured during invasive coronary angiography. The association will be quantified using Pearson's or Spearman's correlation coefficient, as appropriate. The correlation coefficient is dimensionless.
Baseline (during the initial diagnostic assessment)
Correlation Between TAPSE/PASP Ratio and Index of Microcirculatory Resistance (IMR)
Periodo de tiempo: Baseline (during the initial diagnostic assessment)

Correlation between the ratio of tricuspid annular plane systolic excursion to pulmonary artery systolic pressure (TAPSE/PASP), assessed by transthoracic echocardiography as an index of right ventricular-pulmonary arterial coupling, and the index of microcirculatory resistance (IMR), measured during invasive coronary angiography. The association will be quantified using Pearson's or Spearman's correlation coefficient, as appropriate. The correlation coefficient is dimensionless.
Baseline (during the initial diagnostic assessment)
Correlation Between TAPSE/PASP Ratio and cFR
Periodo de tiempo: Baseline (during the initial diagnostic assessment)

Correlation between the echocardiographically assessed TAPSE/PASP ratio, an index of right ventricular-pulmonary arterial coupling, and cFR, measured during invasive coronary angiography. The association will be quantified using Pearson's or Spearman's correlation coefficient, as appropriate. The correlation coefficient is dimensionless.
Baseline (during the initial diagnostic assessment)
Correlation Between TAPSE/PASP Ratio and Resting Full-Cycle Ratio (RFR)
Periodo de tiempo: Baseline (during the initial diagnostic assessment)

Correlation between the echocardiographically assessed TAPSE/PASP ratio, an index of right ventricular-pulmonary arterial coupling, and resting full-cycle ratio (RFR), measured during invasive coronary angiography. The association will be quantified using Pearson's or Spearman's correlation coefficient, as appropriate. The correlation coefficient is dimensionless.
Baseline (during the initial diagnostic assessment)
Number of Distinct Coronary Microvascular Dysfunction Phenotypes Identified by Cluster Analysis
Periodo de tiempo: Baseline (during the initial diagnostic assessment)

Number of distinct phenotypic clusters identified among symptomatic patients with ANOCA or HFpEF using unsupervised cluster analysis of baseline cardiopulmonary exercise testing parameters, echocardiographic markers, and invasive coronary physiological indices.
Baseline (during the initial diagnostic assessment)

Colaboradores e Investigadores

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

Patrocinador

Heart and Diabetes Center North-Rhine Westfalia

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 (Actual)

11 de agosto de 2025

Finalización primaria (Estimado)

1 de junio de 2029

Finalización del estudio (Estimado)

1 de junio de 2029

Fechas de registro del estudio

Enviado por primera vez

11 de agosto de 2025

Primero enviado que cumplió con los criterios de control de calidad

8 de noviembre de 2026

Publicado por primera vez (Actual)

12 de noviembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

12 de noviembre de 2026

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

8 de noviembre de 2026

Última verificación

1 de noviembre de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • HDZ-KA_0525_EMPIRE

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

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. .

Suscribir