Correlation between fractional flow reserve and myocardial viability as assessed by cardiac magnetic resonance imaging in late-presenting asymptomatic STEMI patients

• Conditions: late-presenting asymptomatic STEMI patients who present after 48 hours of symptom; late-presenting STEMI; FFR; MRI; Viability; Revascularization

• Registration Number: TCTR20190306006
• Lead Sponsor: RCT

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-06
• Study Completion: 2019-08-19
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Terminated (Halted Prematurely)
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1.Age >18 years
2.All patients between 18-80 years presenting with STEMI who
-were not treated within 48 hours after the onset of symptom to 14 days and did not have post MI angina with stable clinical more than 4 days
-Failed thrombolytic therapy and did not undergo pharmacoinvasive in 24 hours with stable clinical more than 4 days
3.Angiographic inclusion criteria
-At least 50% to 90% diameter stenosis in an IRA on visual estimation of baseline angiography and judged feasible for treatment with PCI by the operator.
4.Willing to participate and able to understand, read and sign the informed consent document before the planned procedure

Exclusion Criteria

1.Total occlusion of IRA
2.Pregnancy or planning to become pregnant any time after enrolment into this study.
3.Left main stem disease (stenosis > 50%)
4.Known severe cardiac valve dysfunction that will require surgery in the follow-up period.
5.TIMI flow less than 2 of IRA artery.
6.Killip class III or IV at presentation
7.Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
8.Life expectancy of less than one year
9. Inability to tolerate Adenosine
10. Heavily calcified or tortuous vessel where inability to cross the lesion with a pressure wire is expected.
11.Prior history of MI
12. Prior history of revascularization either PCI or CABG

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
FFR value Day 1 Cardiac MRI

Secondary Outcome Measures

Name	Time	Method
Death 12 months Event death,Non-fatal Myocardial infarction (MI) 12 month Event non-fatal myocardial infarction,Delta FFR (post-pre) Day 1 Cardiac MRI,FFR measurement in late-presenting asymptomatic STEMI patients. Day 1 Cardiac revascularization,Unplanned revascularization 12 month Event unplanned revascularization