The Effects of Facilitated Percutaeous Coronary Intervention in Acute Myocardial Infarction

Acute Myocardial Infarction Clinical Trial

Official title:

The Effects of Facilitated Percutaeous Coronary Intervention Compared to Primary Percutaneous Coronary Intervention in Patients With ST-Segment Elevation Acute Myocardial Infarction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00611169
• Other study ID #: 2005-09-007-001
• Status: Completed
• Phase: Phase 4
• First received: January 27, 2008
• Last updated: February 7, 2008
• Start date: January 2006
• Est. completion date: August 2007

Study information

• Verified date: August 2007
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study to investigate whether the administration of high-dose tirofiban before primary PCI could reduce myocardial infarct size, using analysis of contrast-enhanced magnetic resonance imaging.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• presence of chest pain for more than 30 minutes but less than 12 hours after symptom onset

• ST-segment elevation more than 1 mm in two or more contiguous leads or presumably a new-onset left bundle branch blockage

Exclusion Criteria:

• hemodynamic instability

• history of MI

• old age > 80years

• Patients with bleeding diathesis (coagulopathy, thrombocytopenia or platelet dysfunction, Gastrointestinal or genitourinary bleeding within the prior 3 months)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Drug:
• tirofiban
tirofiban (25 µg/kg bolus and 0.15 µg/kg/min maintenance infusion for 24 hours)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infarct size and its transmural extent using MRI		within the first 30 days after index procedure	No
Secondary	pre-PCI thrombolysis in myocardial infarction grade, post-PCI myocardial blush grade, ST-segment resolution on electrocardiography, and left ventricular ejection fraction on echocardiography		at 6 month after index procedure	No