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Clinical Trials/NCT02670005
NCT02670005
Unknown
Not Applicable

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

Nanjing Medical University0 sites600 target enrollmentJuly 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fractional Flow Reserve
Sponsor
Nanjing Medical University
Enrollment
600
Primary Endpoint
Major adverse cardiac events
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2016
End Date
December 2017
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Nanjing Medical University
Responsible Party
Principal Investigator
Principal Investigator

Jin Geng

MD

Nanjing Medical University

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

Outcomes

Primary Outcomes

Major adverse cardiac events

Time Frame: up to 5 years

composite of cardiac death, reinfarction and unplanned hospitalization due to cardiovascular reasons

Secondary Outcomes

  • cardiac death(up to 5 years)
  • unplanned hospitalization due to cardiovascular reasons(up to 5 years)
  • reinfarction(up to 5 years)

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