Prognostic Impact of Cardiac Diastolic Function and Coronary Microvascular Function (DIAST-CMD)

Prospective Registry Evaluating 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.

Study Overview

• Status: Completed
• Conditions: Ischemic Heart Disease; Heart Failure With Preserved Ejection Fraction; Microvascular Coronary Artery Disease; Diastolic Dysfunction
• Intervention / Treatment: Diagnostic test: Echocardiography; Diagnostic test: Coronary flow reserve and index of microcirculatory dysfunction

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.

• Study Type: Observational
• Enrollment (Estimated): 800

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gwangju, Korea, Republic of
    • Chonnam National University Hospital
  • Gwangju, Korea, Republic of
    • Chosun University Hospital
  • Seoul, Korea, Republic of
    • Samsung Medical Center
• United States
  • Iowa
    • Iowa City, Iowa, United States
      • University of Iowa Carver College of Medicine, Iowa City, IA, USA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with cardiac diastolic 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.	Diagnostic test: 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.; Diagnostic test: Coronary flow reserve and index of microcirculatory dysfunction; Coronary microcirculatory dysfunction was defined as having both depressed CFR (≤2.0) and elevated IMR (≥23U).
Patients with coronary microcirculatory dysfunction; Patients with coronary microcirculatory dysfunction was defined as having both depressed CFR (≤2.0) and elevated IMR (≥23U).	Diagnostic test: 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.; Diagnostic test: Coronary flow reserve and index of microcirculatory dysfunction; Coronary microcirculatory dysfunction was defined as having both depressed CFR (≤2.0) and elevated IMR (≥23U).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiovascular death	Cardiovascular death	3 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
all-cause death	all-cause death	3 year
Myocardial infarction	Myocardial infarction according to universal definition of MI	3 year
Any revascularization	Any revascularization according to ARC definition	3 year
Major adverse cardiac events	Major adverse cardiac events (MACEs, a composite of cardiovascular death, MI, and any revascularization)	3 year
Heart failure admission	Admission due to heart failure	3 year

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Collaborators: Chonnam National University Hospital; Chosun University Hospital; Gangneung Asan Hospital
• Investigators: Principal Investigator: Joo Myung Lee, MD, MPH, PhD, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2016
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: September 17, 2021
• First Submitted That Met QC Criteria: September 17, 2021
• First Posted (Actual): September 28, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 12, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: prognosis; coronary flow reserve; diastolic dysfunction; index of microcirculatory resistance; coronary microvascular dysfunction
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia
• Other Study ID Numbers: SMCDIAST119023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The decision of sharing IPD will be determined after discussion by executive committee of the current study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No