Non-culprit Vessels for ST-Segment Elevation Myocardial Infarction

NCT ID: NCT02154919

Last Updated: 2014-06-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 306 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-04-30

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

Conditions

Conservative Pharmacotherapy; Staged Percutaneous Coronary Intervention; Non-culprit Vessels; ST-Segment Elevation Myocardial Infarction

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

complete revascularization group

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.

Percutaneous coronary intervention

Intervention Type: PROCEDURE

conservative pharmacotherapy group

patients in conservative group undergoing pharmacotherapy after PPCI. The drugs were the same between two groups.

No interventions assigned to this group

Interventions

Percutaneous coronary intervention

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Shijitan Hospital, Capital Medical University

OTHER

Sponsor Role: lead

Responsible Party

Peng Jian Jun

Beijing Shijitan Hospital, Capital Medical University , Beijing, China

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beijing Shijitan Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

CPVsSPCI

Identifier Type: -

Identifier Source: org_study_id