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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02670005

Enrollment

600

Registered

2016-02-01

Start date

2016-07-31

Completion date

Unknown

Last updated

2016-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
cardiac death	up to 5 years	All deaths are considered cardiovascular unless an unequivocal noncardiac cause could be established.
reinfarction	up to 5 years	Reinfarction is defined as myocardial infarction after the PCI procedure.
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.

Outcome results