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

8. November 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

120

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Deutschland
    • North Rhine-Westphalia
      • Bad Oeynhausen, North Rhine-Westphalia, Deutschland, 32545

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind
  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Diagnose
  • Zuteilung: Nicht randomisiert
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Sonstiges: patients with ANOCA or HFpEF

Patients with angina and/or exertional dyspnea without obstructive coronary artery disease (ANOCA or HFpEF phenotype).
Diagnosetest: 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
Sonstiges: control participants

Control individuals without evidence of coronary or myocardial disease, microvascular dysfunction or heart failure with preserved ejection fraction
Diagnosetest: 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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Correlation Between Peak Oxygen Uptake (VO₂peak) and Index of Microcirculatory Resistance (IMR)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Correlation Between E/e' Ratio and Index of Microcirculatory Resistance (IMR)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Heart and Diabetes Center North-Rhine Westfalia

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

11. August 2025

Primärer Abschluss (Geschätzt)

1. Juni 2029

Studienabschluss (Geschätzt)

1. Juni 2029

Studienanmeldedaten

Zuerst eingereicht

11. August 2025

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

8. November 2026

Zuerst gepostet (Tatsächlich)

12. November 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

12. November 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

8. November 2026

Zuletzt verifiziert

1. November 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • HDZ-KA_0525_EMPIRE

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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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