Non-culprit Vessels for ST-Segment Elevation Myocardial Infarction

ST-Segment Elevation Myocardial Infarction Clinical Trial

— CPVsSPCI  

Official title:

Conservative Pharmacotherapy Versus Staged Percutaneous Coronary Intervention on Non-culprit Vessels for ST-Segment Elevation Myocardial Infarction Patients With Multivessel Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02154919
• Other study ID #: CPVsSPCI
• Status: Completed
• Phase: N/A
• First received: May 31, 2014
• Last updated: May 31, 2014
• Start date: April 2011

Study information

• Verified date: May 2014
• Source: Beijing Shijitan Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Beijing Municipal Science and Technology Commission
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 306
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Percutaneous coronary intervention

Locations

Country	Name	City	State
China	Beijing Shijitan Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Shijitan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Adverse Cardiovascular Events		360days	Yes