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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT02670005
Other study ID # 20160010
Secondary ID
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. 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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective


Related Conditions & MeSH terms


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
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