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

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ClinicalTrials.gov Identifier: NCT02670005
Recruitment Status : Unknown
Verified January 2016 by Jin Geng, Nanjing Medical University.
Recruitment status was:  Enrolling by invitation
First Posted : February 1, 2016
Last Update Posted : July 26, 2016
Sponsor:
Information provided by (Responsible Party):
Jin Geng, Nanjing Medical University

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).

Condition or disease
Fractional Flow Reserve ST-segment Elevation Myocardial Infarction Percutaneous Coronary Intervention

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.

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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Retrospective
Study Start Date : July 2016
Estimated Primary Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

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



Primary Outcome Measures :
  1. Major adverse cardiac events [ Time Frame: up to 5 years ]
    composite of cardiac death, reinfarction and unplanned hospitalization due to cardiovascular reasons


Secondary Outcome Measures :
  1. cardiac death [ Time Frame: up to 5 years ]
    All deaths are considered cardiovascular unless an unequivocal noncardiac cause could be established.

  2. reinfarction [ Time Frame: up to 5 years ]
    Reinfarction is defined as myocardial infarction after the PCI procedure.

  3. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with ST-segment elevation myocardial infarction received selective percutaneous coronary intervention
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
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Responsible Party: Jin Geng, MD, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT02670005    
Other Study ID Numbers: 20160010
First Posted: February 1, 2016    Key Record Dates
Last Update Posted: July 26, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Myocardial Infarction
ST Elevation Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases