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

July 24, 2016 updated by: Jin Geng, Nanjing Medical University
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).

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

600

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with ST-segment elevation myocardial infarction received selective percutaneous coronary intervention

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

January 26, 2016

First Submitted That Met QC Criteria

January 27, 2016

First Posted (Estimate)

February 1, 2016

Study Record Updates

Last Update Posted (Estimate)

July 26, 2016

Last Update Submitted That Met QC Criteria

July 24, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20160010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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