Percutaneous Coronary Intervention Clinical Trial
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).
Status | Enrolling by invitation |
Enrollment | 600 |
Est. completion date | |
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 |
Observational Model: Cohort, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Nanjing Medical University |
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 |
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