Status:
UNKNOWN
Efficacy of Intracoronary Infusion of Different Medicine in STEMI Patients Undergoing Primary PCI
Lead Sponsor:
RenJi Hospital
Collaborating Sponsors:
Shanghai 10th People's Hospital
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Conditions:
ST Segment Elevation Myocardial Infarction
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
The study intends to evaluate the efficacy of different medicine delivering by targed perfusion catheter incoronary administration on epicardial, myocardial perfusion and clinical outcomes in STEMI pa...
Detailed Description
The goal of STEMI therapy is to successfully restore both epicardial blood flow and myocardial perfusion. PCI has been documented as being the most effective method for restoration of epicardial blood...
Eligibility Criteria
Inclusion
- Age: over 18 or 18 years old, less than 75 years old;
- Patents with myocardial infarction who have symptom onset within 6h before randomization;
- ECG: ≥2 mm ST-segment elevation in 2 contiguous precordial leads or ≥1 mm ST-segment elevation in 2 contiguous extremity leads ;
- Signed informed consent form prior to trial participation.
Exclusion
- Evidence of cardiac rupture;
- ECG: new left bundle branch block;
- Thrombolysis contradictions:
- Severe complication
- Other diseases with life expectancy ≤12 months;
- Any history of Severe renal or hepatic dysfunction(hepatic failure, cirrhosis, portal hypertension and active hepatitis); Neutropenia, thrombocytopenia ; Known acute pancreatitis;
- Known acute pericarditis and/or subacute bacterial endocarditis;
- Arterial aneurysm, arterial/venous malformation and aorta dissection;
- Complex heart condition
- Cardiogenic shock(SBP \<90 mmHg after fluid infusion or SBP\<100 mmHg after vasoactive drugs);
- PCI within previous 1 month or Previous coronary-artery bypass surgery(CABG);
- Previously known multivessel coronary artery disease not suitable for revascularization;
- Hospitalisation for cardiac reason within past 48 hours;
- Not suitable for clinical trial
- Inclusion in another clinical trial;
- Previous enrolment in this study or treatment with an investigational drug or device under another study protocol in the past 7 days;
- Pregnancy or lactating;
- Body weight \<40kg or \>125kg;
- Known hypersensitivity to any drug that may appear in the study;
- Inability to follow the protocol and comply with follow-up requirements or any other reason that the investigator feels would place the patient at increased risk.
Key Trial Info
Start Date :
September 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2019
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT03252665
Start Date
September 1 2017
End Date
June 30 2019
Last Update
August 17 2017
Active Locations (1)
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1
Ren Ji Hospital Afflited to School of Medicine, Shanghai Jiao Tong University
Shanghai, China