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Completed

NCT Number: NCT05058833

Prognostic Impact of Cardiac Diastolic Function and Coronary Microvascular Function

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Chonnam National University Hospital, Gwangju, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Echocardiography

Diagnostic Test

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.

Coronary flow reserve and index of microcirculatory dysfunction

Diagnostic Test

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

Primary outcomes

  1. Cardiovascular death

    Time frame: 3 year

    Cardiovascular death

Secondary outcomes

  1. all-cause death

    Time frame: 3 year

    all-cause death

  2. Myocardial infarction

    Time frame: 3 year

    Myocardial infarction according to universal definition of MI

  3. Any revascularization

    Time frame: 3 year

    Any revascularization according to ARC definition

  4. Major adverse cardiac events

    Time frame: 3 year

    Major adverse cardiac events (MACEs, a composite of cardiovascular death, MI, and any revascularization)

  5. Heart failure admission

    Time frame: 3 year

    Admission due to heart failure

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Collaborators

  • Chonnam National University Hospital
  • Chosun University Hospital
  • Gangneung Asan Hospital

Registry information

Official study title

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

Acronym: DIAST-CMD

Important dates

Study start
2016
Primary completion
2024
Study completion
2024
First posted
Sep 28, 2021
Registry last updated
Mar 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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