Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05058833 |
| Other study ID # |
SMCDIAST119023 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 8, 2016 |
| Est. completion date |
December 31, 2022 |
Study information
| Verified date |
September 2022 |
| Source |
Samsung Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
