Efficacy of Intracoronary Infusion of Different Medicine in STEMI Patients Undergoing Primary PCI

• Status: Unknown status
• Trial end date: 2019-06-30
• Target enrollment: 0
• Participant gender: All

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 patients undergoing primary PCI.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: RenJi Hospital
• Collaborators: Ruijin Hospital; Shanghai 10th People's Hospital; Shanghai 6th People's Hospital; Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine; Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Treatments: Alprostadil; Glucuronyl glucosamine glycan sulfate; Nicorandil; Nitroglycerin

Criteria

Inclusion Criteria:

• 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 Criteria:

1. Evidence of cardiac rupture;

2. ECG: new left bundle branch block;

3. Thrombolysis contradictions:

4. 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;

5. 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;

6. 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.