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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05058833
Recruitment Status : Active, not recruiting
First Posted : September 28, 2021
Last Update Posted : September 9, 2022
Sponsor:
Collaborators:
Chonnam National University Hospital
Chosun University Hospital
Gangneung Asan Hospital
Information provided by (Responsible Party):
Joo Myung Lee, Samsung Medical Center

Study Description
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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.

Condition or disease Intervention/treatment
Ischemic Heart Disease Microvascular Coronary Artery Disease Diastolic Dysfunction Heart Failure With Preserved Ejection Fraction 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 Design
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Study Type : Observational
Estimated Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Registry Evaluating Prognostic Impact of Cardiac Diastolic Function and Coronary Microvascular Function
Actual Study Start Date : April 8, 2016
Actual Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022
Groups and Cohorts
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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).


Outcome Measures
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Primary Outcome Measures :
  1. Cardiovascular death [ Time Frame: 3 year ]
    Cardiovascular death


Secondary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05058833


Locations
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United States, Iowa
University of Iowa Carver College of Medicine, Iowa City, IA, USA
Iowa City, Iowa, United States
Korea, Republic of
Chonnam National University Hospital
Gwangju, Korea, Republic of
Chosun University Hospital
Gwangju, Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Samsung Medical Center
Chonnam National University Hospital
Chosun University Hospital
Gangneung Asan Hospital
Investigators
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Principal Investigator: Joo Myung Lee, MD, MPH, PhD Samsung Medical Center
More Information
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Responsible Party: Joo Myung Lee, Assistant Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT05058833    
Other Study ID Numbers: SMCDIAST119023
First Posted: September 28, 2021    Key Record Dates
Last Update Posted: September 9, 2022
Last Verified: September 2022
Individual Participant Data (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Joo Myung Lee, Samsung Medical Center:
coronary microvascular dysfunction
diastolic dysfunction
coronary flow reserve
index of microcirculatory resistance
prognosis
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
 Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases