Non-culprit Vessels for ST-Segment Elevation Myocardial Infarction

Completed

• Conditions: ST-Segment Elevation Myocardial Infarction; Staged Percutaneous Coronary Intervention; Non-culprit Vessels; Conservative Pharmacotherapy
• Interventions: Procedure: Percutaneous coronary intervention

• Registration Number: NCT02154919
• Lead Sponsor: Beijing Shijitan Hospital, Capital Medical University

Brief Summary

To compare the different effect of conservative pharmacotherapy and Staged Percutaneous Coronary Intervention (SPCI) on significant non-culprit lesions in patients with ST-segment elevation myocardial infarction (STEMI) at presentation remains controversial

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Primary Completion: 2013-12
• Status Verified: 2014-05
• Study First Submitted: 2014-05-31
• Study First Submitted QC: 2014-05-31
• Last Update Submitted: 2014-05-31
• Study First Posted: 2014-06-03
• Last Update Posted: 2014-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 306

Inclusion Criteria

• age 18 to 75 with continuous ischemic chest pain for ≥ 30 minutes and ST-segment of electrocardiographic leads between V2 and V3 elevated ≥ 0.2 mV (or ≥ 0.1 mV in ≥ 2 other continuous electrocardiographic leads), cardiac troponin I (cTn I) elevation of > 0.05 ng/ml, coronary arteriography within 12 hours after the onset of symptoms indicating lesion in culprit vessel with thrombolysis in myocardial infarction (TIMI) flow grade 0 to 1, merely underwent PPCI. Additionally, coronary arteriography corroborates lesions in non-culprit vessel (Besides the culprit vessel, there are ≥ 70% stenoses in one or more coronary vessels in which diameters were ≥ 2 mm).

Exclusion Criteria

• left main coronary artery disease, cardiogenic shock, complete left bundle branch block (CLBBB) PPCI treated culprit and non-culprit vessels, PPCI failure patients with postsurgical haemodynamic instability or spontaneous ischemia, ≥ 70% stenoses of vessels remained during the hospitalization after staged PCI, history of PCI or Coronary Artery Bypass Grafting (CABG), history of chronic cardiac failure, bleeding diathesis, prior administration of thrombolytic therapy, known thrombopenia or leucopenia, sever liver and kidney dysfunction, active infection, immune system and connective tissue diseases, known contraindications to aspirin or heparin, life expectancy < 1 year, had major procedure within 3 months, uncontrolled hypertension, ischemic stroke within 30 days, hemorrhagic stroke, intracranial diseases including and arteriovenous malformation, extensive traumatic cerebral infarction within 6 weeks, oral anticoagulant therapy, severe myocardial infarction related complications and perioperative death

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
complete revascularization group	Percutaneous coronary intervention	this group underwent second PCI procedure on the non-culprit vessels and reveived 100-120 IU/kg unfractionated heparin during PPCI, followed by 3 days administration of low molecular weight heparin or Fondaparinux sodium after procedure. Patients in the CP group and CR group after second PCI procedure were given conservative medicine such as Statins which were not contraindicated to the patients.

Primary Outcome Measures

Name	Time	Method
Major Adverse Cardiovascular Events	360days

Trial Locations

Locations (1)

Beijing Shijitan Hospital; 🇨🇳 Beijing, Beijing, China