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

Percutaneous Coronary Intervention Clinical Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02670005
• Other study ID #: 20160010
• Status: Enrolling by invitation
• Phase: N/A
• First received: January 26, 2016
• Last updated: July 24, 2016
• Start date: July 2016

Study information

• Verified date: January 2016
• Source: Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: the ethics committee of Huai'an First People's Hospital: China
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 600
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse cardiac events	composite of cardiac death, reinfarction and unplanned hospitalization due to cardiovascular reasons	up to 5 years	Yes
Secondary	cardiac death	All deaths are considered cardiovascular unless an unequivocal noncardiac cause could be established.	up to 5 years	Yes
Secondary	reinfarction	Reinfarction is defined as myocardial infarction after the PCI procedure.	up to 5 years	Yes
Secondary	unplanned hospitalization due to cardiovascular reasons	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.	up to 5 years	Yes