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.
研究概览
地位
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Muhammed Gercek
- 电话号码：0049571971258
- 邮箱：mugercek@hdz-nrw.de
学习地点
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North Rhine-Westphalia
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Bad Oeynhausen、North Rhine-Westphalia、德国、32545
- 招聘中
- Heart and Diabetes Center NRW
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接触：
- Muhammed Gerçek, MD
- 电话号码：+495731971258
- 邮箱：mugercek@hdz-nrw.de
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接触：
- Lena Riemke-Maw
- 邮箱：lriemke-maw@hdz-nrw.de
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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其他：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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其他：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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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Correlation Between Peak Oxygen Uptake (VO₂peak) and Index of Microcirculatory Resistance (IMR)
大体时间：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
大体时间：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)
大体时间：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)
大体时间：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
大体时间：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)
大体时间：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)
大体时间：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
大体时间：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)
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Correlation Between E/e' Ratio and Index of Microcirculatory Resistance (IMR)
大体时间：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
大体时间：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)
大体时间：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)
大体时间：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
大体时间：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)
大体时间：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)
大体时间：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
大体时间：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)
大体时间：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
大体时间：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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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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