Clinical trial NCT05058833: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Heart Disease
Microvascular Coronary Artery Disease
Diastolic Dysfunction
Heart Failure With Preserved Ejection Fraction
Keywords: coronary microvascular dysfunction
diastolic dysfunction
coronary flow reserve
index of microcirculatory resistance
prognosis
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Chonnam National University Hospital
name: Chosun University Hospital
name: Gangneung Asan Hospital
First posted: 2021-09-28
Enrollment: 800
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Cardiovascular death
timeFrame: 3 year
Secondary outcomes:
measure: all-cause death
timeFrame: 3 year
measure: Myocardial infarction
timeFrame: 3 year
measure: Any revascularization
timeFrame: 3 year
measure: Major adverse cardiac events
timeFrame: 3 year
measure: Heart failure admission
timeFrame: 3 year
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Carver College of Medicine, Iowa City, IA, USA
state: Iowa
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Gwangju
country: Korea, Republic of
facility: Chosun University Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Joo Myung Lee, MD, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References: