Prognostic Impact of Cardiac Diastolic Function and Coronary Microvascular Function
- Conditions
- Ischemic Heart DiseaseDiastolic DysfunctionMicrovascular Coronary Artery DiseaseHeart Failure With Preserved Ejection Fraction
- Interventions
- Diagnostic Test: EchocardiographyDiagnostic Test: Coronary flow reserve and index of microcirculatory dysfunction
- Registration Number
- NCT05058833
- Lead Sponsor
- Samsung Medical Center
- Brief Summary
The DIAST-CMD registry (Prognostic Impact of Cardiac Diastolic Function and Coronary Microvascular Function) is prospective registry which enrolled patients who underwent echocardiography, cnically-indicated invasive coronary angiography and comprehensive physiologic assessments including fractional flow reserve (FFR), CFR, and IMR measurements for at least 1 vessel from Samsung Medical Center. Patients with hemodynamic instability, severe LV dysfunction (left ventricular ejection fraction\<40%), a culprit vessel of acute coronary syndrome, severe valvular stenosis or regurgitation were excluded.
- Detailed Description
Cardiac diastolic dysfunction refers to a condition in which abnormalities in mechanical function are present during diastole and is an independent predictor of mortality, even in patients with preserved left ventricular (LV) systolic function. Clinical manifestations of cardiac diastolic dysfunction are also variable, from asymptomatic subclinical heart failure to heart failure with preserved ejection fraction, angina or exercise intolerance without significant epicardial coronary artery disease, or end-stage heart failure. Although its pathophysiology remains incompletely understood, findings from clinical and pre-clinical studies have suggested systemic endothelial dysfunction, oxidative stress, and coronary microvascular dysfunction (CMD) could be important pathophysiologic mechanisms for cardiac diastolic dysfunction.
In this regard, recent studies evaluated non-invasively measured coronary flow reserve (CFR) from positron emission tomography (PET), cardiac magnetic resonance imaging (MRI), or Doppler echocardiography, and presented the association of depressed global CFR with cardiac diastolic dysfunction and higher risk of clinical events. The presence of CMD can be also evaluated by invasive physiologic assessment using both CFR and index of microcirculatory resistance (IMR). Previous studies presented CMD could be one of the major causes of angina without significant epicardial coronary artery disease and an independent predictor of adverse clinical events in patients with stable ischemic heart disease, acute myocardial infarction (MI), or myocardial disease. Nevertheless, there has been limited study which evaluated the association between cardiac diastolic dysfunction and CMD using invasive physiologic indices and their prognostic implications, especially in non-MI patients without significant coronary artery stenosis.
Therefore, the current study was designed the current DIAST-CMD registry to evaluate 3 important clinical questions as to whether: (1) cardiac diastolic dysfunction is significantly associated with the presence of CMD; 2) both cardiac diastolic dysfunction and CMD are significantly associated with long-term cardiovascular death; and 3) integration of both disease entities would have incremental prognostic stratification in non-MI patients without significant epicardial coronary artery disease.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 800
- Patients who underwent clinically-indicated invasive coronary angiography
- Patients who underwent comprehensive physiologic assessments
- Patients who were evaluated by echocardiography
- Patients with unavailable echocardiography data
- Patients with hemodynamic instability
- Patients with severe LV dysfunction (LV ejection fraction<30%)
- Patients with severe valvular stenosis or regurgitation
- Culprit vessel of acute coronary syndrome
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with cardiac diastolic dysfunction Echocardiography Echocardiographic grades of diastolic function was defined according to 2016 ASE/EACVI recommendations for the evaluation of LV diastolic function. Cardiac diastolic dysfunction was defined as elevated E/e'≥15. Patients with coronary microcirculatory dysfunction Coronary flow reserve and index of microcirculatory dysfunction Patients with coronary microcirculatory dysfunction was defined as having both depressed CFR (≤2.0) and elevated IMR (≥23U). Patients with cardiac diastolic dysfunction Coronary flow reserve and index of microcirculatory dysfunction Echocardiographic grades of diastolic function was defined according to 2016 ASE/EACVI recommendations for the evaluation of LV diastolic function. Cardiac diastolic dysfunction was defined as elevated E/e'≥15. Patients with coronary microcirculatory dysfunction Echocardiography Patients with coronary microcirculatory dysfunction was defined as having both depressed CFR (≤2.0) and elevated IMR (≥23U).
- Primary Outcome Measures
Name Time Method Cardiovascular death 3 year Cardiovascular death
- Secondary Outcome Measures
Name Time Method Myocardial infarction 3 year Myocardial infarction according to universal definition of MI
Major adverse cardiac events 3 year Major adverse cardiac events (MACEs, a composite of cardiovascular death, MI, and any revascularization)
all-cause death 3 year all-cause death
Any revascularization 3 year Any revascularization according to ARC definition
Heart failure admission 3 year Admission due to heart failure
Trial Locations
- Locations (4)
University of Iowa Carver College of Medicine, Iowa City, IA, USA
🇺🇸Iowa City, Iowa, United States
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Chosun University Hospital
🇰🇷Gwangju, Korea, Republic of
Chonnam National University Hospital
🇰🇷Gwangju, Korea, Republic of