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

• ClinicalTrials.gov Identifier: NCT05058833
• Recruitment Status: Active, not recruiting
• First Posted: September 28, 2021
• Last Update Posted: September 9, 2022
• Sponsor: Samsung Medical Center
• Collaborators: Chonnam National University Hospital; Chosun University Hospital; Gangneung Asan Hospital
• Information provided by (Responsible Party): Joo Myung Lee, Samsung Medical Center

Tracking Information

• First Submitted Date: September 17, 2021
• First Posted Date: September 28, 2021
• Last Update Posted Date: September 9, 2022
• Actual Study Start Date: April 8, 2016
• Actual Primary Completion Date: December 31, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 17, 2021)

Cardiovascular death [ Time Frame: 3 year ]

Cardiovascular death

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 17, 2021)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Prognostic Impact of Cardiac Diastolic Function and Coronary Microvascular Function
• Official Title: Prospective Registry Evaluating Prognostic Impact of Cardiac Diastolic Function and Coronary Microvascular Function
• 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.

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.

Condition

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

Intervention

• 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).

Study Groups/Cohorts

• 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.
  Interventions:

  • Diagnostic Test: Echocardiography
  • Diagnostic Test: Coronary flow reserve and index of microcirculatory dysfunction
• Patients with coronary microcirculatory dysfunction
  Patients with coronary microcirculatory dysfunction was defined as having both depressed CFR (≤2.0) and elevated IMR (≥23U).
  Interventions:

  • Diagnostic Test: Echocardiography
  • Diagnostic Test: Coronary flow reserve and index of microcirculatory dysfunction

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: September 17, 2021): 800
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2022
• Actual Primary Completion Date: December 31, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Korea, Republic of, United States

Administrative Information

• NCT Number: NCT05058833
• Other Study ID Numbers: SMCDIAST119023
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided
• Plan Description: The decision of sharing IPD will be determined after discussion by executive committee of the current study.

• Current Responsible Party: Joo Myung Lee, Samsung Medical Center
• Original Responsible Party: Same as current
• Current Study Sponsor: Samsung Medical Center
• Original Study Sponsor: Same as current

Collaborators

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

Investigators

• Principal Investigator: Joo Myung Lee, MD, MPH, PhD; Samsung Medical Center

• PRS Account: Samsung Medical Center
• Verification Date: September 2022