CHINA
Beijing, China
NCT Number: NCT03445728
We compared the infarct size in ST-segment elevation myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention (PCI) treated by nicorandil before and after the reperfusion with those standard therapy treated by PCI
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Notify Me18 year–80 year
All sexes
Interventional
Phase 4
Beijing, China
The aim of this study was to evaluate the efficacy and safety of nicorandil in improving myocardial infarct size in patients with acute myocardial infarction through a multi-center, prospective, randomized, double-blind and parallel-controlled clinical study, providing evidence-based support for the optimization of PCI treatment strategies. The primary objective of the study was to compare whether the effect of nicorandil in combination with PCI was significantly better at reducing the myocardial infarct size than that of PCI alone in AMI patients.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
After randomization, receive primary PCI and standard therapy, 12mg Nicorandil iv. just before ballooning or stenting, then keep Nicorandil 6mg/h ivgtt. up to 24h
After randomization, receive primary PCI and standard therapy, just like the intervension group also iv. just before ballooning or stenting, then keep ivgtt. up to 24h
Time frame: 7 days after primary PCI
The myocardial infarct size was derived by measuring the area of delay-enhanced image-enhanced MRI, which was judged and analyzed by two experienced MRI cardiac diagnosticians.
Time frame: 6 months after PCI
The myocardial infarct size was derived from the program's automatic analysis of delayed enhancement images.
Time frame: 5 minutes after stent implantation during PCI
the starting point is the number of frames in which the contrast agent completely or nearly completely filled the beginning of the coronary artery and touched both sides of the coronary vessel wall, and the end point is the number of frames in which the contrast agent entered the distal branch vessel and developed a specific anatomical marker
Time frame: 5 minutes after stent implantation during PCI
When scanning at a rate of 15 frames per second, cTFC > 27 frames per second was used as the criterion for the diagnosis of slow blood flow after primary PCI
Time frame: 2 hours after the procedure
Complete ST-segment resolution at 2 h after PCI
Time frame: Baseline, 6, 12, 18, 24 hours after the PCI
Change of serum creatinine kinase
Time frame: 7 days after the procedure
Edema size
Time frame: 7 days after the procedure
Microvascular obstructionmeasured
Time frame: 7 days after the procedure
LV Ejection fraction in early phase
Time frame: 6 months after the procedure
LV Ejection fraction in late phase
Time frame: up to 12 months
all-cause death, cardiovascular death, , Rehospitalization for heart failure, Unplanned PCI After PPCI
Time frame: 48-72 hours after primary PCI
contrast induced nephropathy
Chinese PLA General Hospital
Other
Effects of Nicorandil on Cardiac Infarct Size in Patients With ST-segment Elevation Acute Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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