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

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

Status
Unknown
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON34319
Enrollment
50
Registered
2010-11-04
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary artery disease multivessel disease

Interventions

None listed

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Accuracy defined as difference between FFR in the acute phase and second procedure (delta FFR).

Secondary

MeasureTime frame
Feasibility defined as completion of the FFR protocol and safety measured as procedural time, contrast volume used and procedural complications (bleeding, dissection, perforation, reinfarction).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)