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.
調査の概要
状態
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Muhammed Gercek
- 電話番号：0049571971258
- メール：mugercek@hdz-nrw.de
研究場所
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North Rhine-Westphalia
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Bad Oeynhausen、North Rhine-Westphalia、ドイツ、32545
- 募集
- Heart and Diabetes Center NRW
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コンタクト：
- Muhammed Gerçek, MD
- 電話番号：+495731971258
- メール：mugercek@hdz-nrw.de
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コンタクト：
- Lena Riemke-Maw
- メール：lriemke-maw@hdz-nrw.de
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：診断
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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他の：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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他の：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Correlation Between Peak Oxygen Uptake (VO₂peak) and Index of Microcirculatory Resistance (IMR)
時間枠：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
時間枠：Baseline (during the initial diagnostic assessment)
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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)
時間枠：Baseline (during the initial diagnostic assessment)
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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)
時間枠：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
時間枠：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)
時間枠：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 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)
時間枠：Baseline (during the initial diagnostic assessment)
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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
時間枠：Baseline (during the initial diagnostic assessment)
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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)
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Correlation Between E/e' Ratio and Index of Microcirculatory Resistance (IMR)
時間枠：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
時間枠：Baseline (during the initial diagnostic assessment)
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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)
時間枠：Baseline (during the initial diagnostic assessment)
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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)
時間枠：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
時間枠：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 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)
時間枠：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 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)
時間枠：Baseline (during the initial diagnostic assessment)
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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
時間枠：Baseline (during the initial diagnostic assessment)
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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)
時間枠：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
時間枠：Baseline (during the initial diagnostic assessment)
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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)
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主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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最終確認日
詳しくは
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