To check safety of nicorandil medicine in heart disease patient
- Conditions
- Health Condition 1: I228- Subsequent ST elevation (STEMI) myocardial infarction of other sites
- Registration Number
- CTRI/2023/11/060118
- Lead Sponsor
- Torrent Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Male Or Female Patients More Than 18 years Of Age
Cases Of ACS NSTEMI STEMI or Unstable Angina with Multivessel Disease And SYNTAX score is less then 35 Requiring Revascularization Or PCI OR
Cases of ACS and Type 2 MI With The Presence of Non Obstructive Coronary Artery On Angiography Defined As No Coronary Artery Stenosis 50 percentage In Any Potential Infarct related Artery
Cases With persistent Systolic Blood pressure Less Than 100mmhg Following Revascularization
Cardiac shock
Aortic Dissection
History Of Myocardial Infarction Or Percutaneous Coronary Intervention Or Coronary Artery Bypass Grafting Less than 1 Month
Cases Requiring Addon Nicorandil Inj To Intravenous Nitrates Before Percutaneous Coronary Intervention
Contraindicated Or Intolerable To Nicorandil Pregnant Or Lactation Period
Patients With An Estimated Survival Time Of Less Than 1 year
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of slow re flow or no reflow Time Frame 3 minutes after primary PCI final coronary flow in the culprit artery <br/ ><br> <br/ ><br>Rate of complete or more than 50 percent ST segment resolution on ECG Time Frame 2 hours after primary PCITimepoint: Followup after 3 minutes of PCI <br/ ><br> <br/ ><br>Followup after 2 hour of primary PCI
- Secondary Outcome Measures
Name Time Method Cardiac Troponin I(cTnI)and CK MB levels at 72 hour <br/ ><br>Percent cases with persistent angina or pain despite revascularization PCI at 4and 12 week with no collateral artery closure or embolization <br/ ><br>Safety assessments in terms of AEs at 12week <br/ ><br>Rate of slow or no-reflow for the subgroups withT2Dor polyvascular or diffuse disease or smokersTimepoint: Followup at 72 hours <br/ ><br>Followup at 4 weeks 12 weeks <br/ ><br>Followup at 12 weeks <br/ ><br>