Intracoronary of Nicorandil and Verapamil to Reduce the Occurrence of Periprocedural Myocardial Injury
Status:
Recruiting
Trial end date:
2023-09-17
Target enrollment:
Participant gender:
Summary
Percutaneous coronary intervention (PCI) remains the major revascularization strategy for
patients with obstructive coronary artery disease (CAD).However,in a substantial number of
PCI cases for acute coronary syndrome (ACS) and chronic coronary syndrome
(CCS),periprocedural myocardial injury or myocardial infarction (MI) occurs,both these
PCI-related complications may be associated with an increased risk of future major adverse
cardiovascular events (such as death, re-infarction, and revascularization).The incidence of
periprocedural myocardial injury varies according to the different definition and cardiac
biomarker .For 4th UDMI criteria with hs-cTn, 78% to 85% patients who undergoing elective PCI
may suffer from periprocedural myocardial injury.
Experimental and clinical evidence highlight the abnormalities of the coronary
microcirculation is one of the causes of myocardial ischemia.Coronary microvascular
disturbances (CMD) have been associated with early stages of atherosclerosis even prior to
any angiographic evidence of epicardial coronary stenosis, as well as to other cardiac
pathologies such as myocardial hypertrophy and heart failure.
In this study, we try to conduct a double blinded, randomized, placebo-controlled trial，the
aim of our trial is: (1) to observe whether the prophylactically intracoronary administration
of nicorandil and verapamil could reduce the occurrence of periprocedural myocardial injury
and infarction in CAD patients undergoing elective PCI.;(2) to observe whether the
prophylactically intracoronary administration of nicorandil and verapamil has protective
effect on coronary microcirculation after elective PCI.
Phase:
Phase 2
Details
Lead Sponsor:
The First Affiliated Hospital of Zhejiang Chinese Medical University