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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 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

120

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiekontakt

Studiesteder

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

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

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Diagnostisk
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Annen: patients with ANOCA or HFpEF

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

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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Correlation Between Peak Oxygen Uptake (VO₂peak) and Index of Microcirculatory Resistance (IMR)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Correlation Between E/e' Ratio and Index of Microcirculatory Resistance (IMR)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)

Samarbeidspartnere og etterforskere

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Sponsor

Heart and Diabetes Center North-Rhine Westfalia

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 (Faktiske)

11. august 2025

Primær fullføring (Antatt)

1. juni 2029

Studiet fullført (Antatt)

1. juni 2029

Datoer for studieregistrering

Først innsendt

11. august 2025

Først innsendt som oppfylte QC-kriteriene

8. november 2026

Først lagt ut (Faktiske)

12. november 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

12. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • HDZ-KA_0525_EMPIRE

Plan for individuelle deltakerdata (IPD)

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Studerer et amerikansk FDA-regulert medikamentprodukt

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Nei

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