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Prognostic Impact of Cardiac Diastolic Function and Coronary Microvascular Function

Prospective Registry Evaluating Prognostic Impact of Cardiac Diastolic Function and Coronary Microvascular Function

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05058833
Acronym
DIAST-CMD
Enrollment
800
Registered
2021-09-28
Start date
2016-04-08
Completion date
2024-12-31
Last updated
2025-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diastolic Dysfunction, Heart Failure With Preserved Ejection Fraction, Ischemic Heart Disease, Microvascular Coronary Artery Disease

Keywords

coronary microvascular dysfunction, diastolic dysfunction, coronary flow reserve, index of microcirculatory resistance, prognosis

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.

Interventions

DIAGNOSTIC_TESTEchocardiography

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.

DIAGNOSTIC_TESTCoronary flow reserve and index of microcirculatory dysfunction

Coronary microcirculatory dysfunction was defined as having both depressed CFR (≤2.0) and elevated IMR (≥23U).

Sponsors

Chonnam National University Hospital
CollaboratorOTHER
Chosun University Hospital
CollaboratorOTHER
Gangneung Asan Hospital
CollaboratorOTHER
Samsung Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Patients who underwent clinically-indicated invasive coronary angiography * Patients who underwent comprehensive physiologic assessments * Patients who were evaluated by echocardiography

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Cardiovascular death3 yearCardiovascular death

Secondary

MeasureTime frameDescription
all-cause death3 yearall-cause death
Myocardial infarction3 yearMyocardial infarction according to universal definition of MI
Any revascularization3 yearAny revascularization according to ARC definition
Major adverse cardiac events3 yearMajor adverse cardiac events (MACEs, a composite of cardiovascular death, MI, and any revascularization)
Heart failure admission3 yearAdmission due to heart failure

Countries

South Korea, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026