Fractional Flow Reserve Versus Angiography for Guiding Selective Percutaneous Coronary Intervention in ST-segment Elevation Myocardial Infarction

• Conditions: ST-segment Elevation Myocardial Infarction; Fractional Flow Reserve; Percutaneous Coronary Intervention

• Registration Number: NCT02670005
• Lead Sponsor: Nanjing Medical University

Brief Summary

To assess the outcomes of patients with ST-segment elevation myocardial infarction (STEMI) assigned to fractional flow reserve (FFR) and angiography-guided selective percutaneous coronary intervention (PCI).

Detailed Description

The investigators retrospectively collect STEMI patients received selective PCI from Jan 2012 to Dec 2015. Clinical follow-up is performed from the date of FFR assessment to Dec 2016 or death, which is up to 5 years. The primary endpoint is major adverse cardiac events, composite of cardiac death, reinfarction and unplanned hospitalization due to cardiovascular reasons. The primary endpoints are cardiac death, reinfarction and unplanned hospitalization due to cardiovascular reasons. All deaths are considered cardiovascular unless an unequivocal noncardiac cause could be established. Reinfarction is defined as myocardial infarction after the PCI procedure. Unplanned hospitalization will be present only if the patient is hospitalized unexpectedly because of persisting or increasing complaints of angina, ventricular arrhythmias and heart failure. All patients were received FFR-guided PCI or angiography-guided PCI before enrollment, and the investigators do not assign specific interventions to the subjects during the study. So this study might be considered to be observational.

Study Timeline

• Status Verified: 2016-01
• Study First Submitted: 2016-01-26
• Study First Submitted QC: 2016-01-27
• Study First Posted: 2016-02-01
• Study Start: 2016-07
• Last Update Submitted: 2016-07-24
• Last Update Posted: 2016-07-26
• Primary Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• age>18 years
• documented acute ST-segment elevation myocardial infarction
• onset of symptom >6 days before percutaneous coronary intervention
• eligible for PCI

Exclusion Criteria

• cardiogenic shock or hemodynamic instability
• highly tortuous or calcified arteries
• infarct related artery with a diameter < 2.5mm
• a life expectancy< 2 years
• intolerance to anti-platelet drugs
• left main disease (≥ 50% stenosis)
• contraindication to adenosine
• hypertrophic cardiomyopathy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Major adverse cardiac events	up to 5 years	composite of cardiac death, reinfarction and unplanned hospitalization due to cardiovascular reasons

Secondary Outcome Measures

Name	Time	Method
cardiac death	up to 5 years	All deaths are considered cardiovascular unless an unequivocal noncardiac cause could be established.
unplanned hospitalization due to cardiovascular reasons	up to 5 years	Unplanned hospitalization will be present only if the patient is hospitalized unexpectedly because of persisting or increasing complaints of angina, ventricular arrhythmias and heart failure.
reinfarction	up to 5 years	Reinfarction is defined as myocardial infarction after the PCI procedure.