The accuracy, feasibility and safety of Fractional Flow Reserve in patients with acute ST-elevation myocardial infarctio

Withdrawn

Conditions: Coronary artery disease
multivessel disease
10011082

Registration Number: NL-OMON34319

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 50

Inclusion Criteria

- A diagnosis of a STEMI defined by 1/A diagnosis of acute MI defined by chest pain suggestive for myocardial ischemia for at least 30 minutes, with a time from onset of symptoms of less than 12 hours, before hospital admission, 2/ ECG with ST- segment deviation of more than 0.1 mV in 2 or more leads and 3/Positive cardiac troponin T >0.01 *g/l.
- Clinical indication for urgent PCI of the infarct related lesion as identified at coronary angiography
- Planned staged PCI for a lesion in a non-infarct related vessel
- Verbal followed by written informed consent
- 18 years or older

Exclusion Criteria

- Presence of cardiogenic shock
- Implantation or planned implantation of an intra-aortic balloon pump
- Failed reperfusion of the infarct related vessel (>30% residual stenosis and less than TIMI 3 coronary flow)
- No staged PCI possible
- Need for coronary artery bypass grafting
- No suitable anatomy of the non-IRV (Left main stenosis of >50%, Diameter <2.5mm, Extremely tortuous or calcified coronary arteries, Chronic total occlusion, Collaterals visible, Previous CABG
- Contra-indications for adenosine intracoronary (Second or third degree AV block, Sick sinus syndrome, Asthma, Hypersensitivity to adenosine)
- Inability to provide informed consent

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Accuracy defined as difference between FFR in the acute phase and second<br /><br>procedure (delta FFR). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Feasibility defined as completion of the FFR protocol and safety measured as<br /><br>procedural time, contrast volume used and procedural complications (bleeding,<br /><br>dissection, perforation, reinfarction).</p><br>