Exercise Metrics and Perfusion Indices in CoRonary Microvascular Dysfunction: A Multimodal Correlative Study in ANOCA and HFpEF Patients (EMPIRE-Trial)
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.
Przegląd badań
Status
Status
Warunki
Warunki
Interwencja / Leczenie
Interwencja / Leczenie
Typ studiów
Typ studiów
Zapisy (Szacowany)
Zapisy
Faza
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
Kontakt w sprawie studiów
- Nazwa: Muhammed Gercek
- Numer telefonu: 0049571971258
- E-mail: mugercek@hdz-nrw.de
Lokalizacje studiów
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North Rhine-Westphalia
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Bad Oeynhausen, North Rhine-Westphalia, Niemcy, 32545
- Rekrutacyjny
- Heart and Diabetes Center NRW
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Kontakt:
- Muhammed Gerçek, MD
- Numer telefonu: +495731971258
- E-mail: mugercek@hdz-nrw.de
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Kontakt:
- Lena Riemke-Maw
- E-mail: lriemke-maw@hdz-nrw.de
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Kryteria uczestnictwa
Kryteria kwalifikacji
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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:
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• 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 studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Diagnostyczny
- Przydział: Nielosowe
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Liczba ramion
Broń i interwencje
Grupa uczestników / ArmGrupa uczestników / Arm |
Interwencja / LeczenieInterwencja / Leczenie |
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Inny: patients with ANOCA or HFpEF
Patients with angina and/or exertional dyspnea without obstructive coronary artery disease (ANOCA or HFpEF phenotype). |
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:
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Inny: control participants
Control individuals without evidence of coronary or myocardial disease, microvascular dysfunction or heart failure with preserved ejection fraction |
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:
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Co mierzy badanie?
Podstawowe miary wyniku
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Correlation Between Peak Oxygen Uptake (VO₂peak) and Index of Microcirculatory Resistance (IMR)
Ramy czasowe: Baseline (during the initial diagnostic assessment)
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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)
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Correlation Between Peak Oxygen Uptake (VO₂peak) and CFR
Ramy czasowe: 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)
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Correlation Between Peak Oxygen Uptake (VO₂peak) and Resting Full-Cycle Ratio (RFR)
Ramy czasowe: 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)
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Correlation Between VE/VCO₂ Slope and Index of Microcirculatory Resistance (IMR)
Ramy czasowe: Baseline (during the initial diagnostic assessment)
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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)
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Correlation Between VE/VCO₂ Slope and CFR
Ramy czasowe: Baseline (during the initial diagnostic assessment)
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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)
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Correlation Between VE/VCO₂ Slope and Resting Full-Cycle Ratio (RFR)
Ramy czasowe: 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)
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Correlation Between Oxygen Pulse and Index of Microcirculatory Resistance (IMR)
Ramy czasowe: 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)
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Correlation Between Oxygen Pulse and CFR
Ramy czasowe: 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)
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Correlation Between Oxygen Pulse and Resting Full-Cycle Ratio (RFR)
Ramy czasowe: Baseline (during the initial diagnostic assessment)
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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)
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Miary wyników drugorzędnych
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Correlation Between E/e' Ratio and Index of Microcirculatory Resistance (IMR)
Ramy czasowe: Baseline (during the initial diagnostic assessment)
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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)
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Correlation Between E/e' Ratio and cFR
Ramy czasowe: 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)
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Correlation Between E/e' Ratio and Resting Full-Cycle Ratio (RFR)
Ramy czasowe: 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)
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Correlation Between Left Atrial Volume Index (LAVI) and Index of Microcirculatory Resistance (IMR)
Ramy czasowe: Baseline (during the initial diagnostic assessment)
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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)
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Correlation Between Left Atrial Volume Index (LAVI) and cFR
Ramy czasowe: 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)
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Correlation Between Left Atrial Volume Index (LAVI) and Resting Full-Cycle Ratio (RFR)
Ramy czasowe: 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)
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Correlation Between TAPSE/PASP Ratio and Index of Microcirculatory Resistance (IMR)
Ramy czasowe: 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)
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Correlation Between TAPSE/PASP Ratio and cFR
Ramy czasowe: 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)
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Correlation Between TAPSE/PASP Ratio and Resting Full-Cycle Ratio (RFR)
Ramy czasowe: 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)
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Number of Distinct Coronary Microvascular Dysfunction Phenotypes Identified by Cluster Analysis
Ramy czasowe: 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)
|
Współpracownicy i badacze
Sponsor
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Rozpoczęcie studiów
Zakończenie podstawowe (Szacowany)
Zakończenie podstawowe
Ukończenie studiów (Szacowany)
Ukończenie studiów
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Pierwszy wysłany
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia wysłana aktualizacja
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
- Techniki śledcze
- Techniki i procedury diagnostyczne
- Diagnoza
- Obrazowanie diagnostyczne
- Techniki diagnostyczne, układ oddechowy
- Techniki diagnostyczne, sercowo -naczyniowe
- Testy funkcji serca
- Testy funkcji oddechowych
- Ergometria
- Techniki obrazowania serca
- Ultrasonografia
- Test ćwiczeń
- Echokardiografia
Inne numery identyfikacyjne badania
Inne numery identyfikacyjne badania
- HDZ-KA_0525_EMPIRE
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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