Ignite Creation Date:
2024-05-06 @ 5:41 PM
Last Modification Date:
2024-10-26 @ 2:34 PM
Study NCT ID:
NCT05399576
Status:
UNKNOWN
Last Update Posted:
2022-06-01
First Post:
2022-05-27
Brief Title:
Intracoronary of Nicorandil and Verapamil to Reduce the Occurrence of Periprocedural Myocardial Injury
Sponsor:
The First Affiliated Hospital of Zhejiang Chinese Medical University
Organization:
The First Affiliated Hospital of Zhejiang Chinese Medical University
Study Overview
Official Title:
The Preventive Effect of Combined Intracoronary of Nicorandil and Verapamil on Myocardial Injury in Preioperative Period of PCI
Status:
UNKNOWN
Status Verified Date:
2022-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Percutaneous coronary intervention PCI remains the major revascularization strategy for patients with obstructive coronary artery disease CADHoweverin a substantial number of PCI cases for acute coronary syndrome ACS and chronic coronary syndrome CCSperiprocedural myocardial injury or myocardial infarction MI occursboth these PCI-related complications may be associated with an increased risk of future major adverse cardiovascular events such as death re-infarction and revascularizationThe 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 ischemiaCoronary 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 trialthe 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 PCI2 to observe whether the prophylactically intracoronary administration of nicorandil and verapamil has protective effect on coronary microcirculation after elective PCI
Experimental and clinical evidence highlight the abnormalities of the coronary microcirculation is one of the causes of myocardial ischemiaCoronary 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 trialthe 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 PCI2 to observe whether the prophylactically intracoronary administration of nicorandil and verapamil has protective effect on coronary microcirculation after elective PCI
Detailed Description:
Simple randomization in a 11 ratio will be made in blocks of variable size according to a random numbers generated by Excel 2019 to divide the patients to treatment group Nicorandil and verapamil and control group Saline The primary end points are the incidence of periprocedural myocardial injury and 4a MI and the level of the IMRsecondary end points include levels of hs-cTnI CK-MB NT-proBNP and hs-CRP before and 24 hours following PCI and major adverse cardiovascular events at day 30 SPSS 260 will be used and P-value 05 will be considered statistically signifificant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None