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

NCT ID: NCT02670005

Last Updated: 2016-07-26

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-07-31

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

FFR-PCI group

patients with ST-segment elevation myocardial infarction (STEMI) who received fractional flow reserve (FFR)-guided selective percutaneous coronary intervention (PCI)

No interventions assigned to this group

angiography-PCI group

patients with STEMI who received angiography-guided selective PCI

No interventions assigned to this group

Eligibility Criteria

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

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

Sponsors

Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Jin Geng

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

20160010

Identifier Type: -

Identifier Source: org_study_id