The objective is to investigate the accuracy, feasibility and safety of FFR in patients presenting with STEMI and MVD.
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Accuracy defined as difference between FFR in the acute phase and second
procedure (delta FFR).
Secondary outcome
Feasibility defined as completion of the FFR protocol and safety measured as
procedural time, contrast volume used and procedural complications (bleeding,
dissection, perforation, reinfarction).
Background summary
Fractional Flow Reserve(FFR)-guided percutaneous coronary intervention (PCI) in
elective patients with multivessel disease (MVD) has proven to limit
unnecessary PCIs in clinical irrelevant lesions. It is currently unclear
whether FFR is also accurate, feasible and safe when used in the acute phase of
a ST-elevation myocardial infarction (STEMI).
Study objective
The objective is to investigate the accuracy, feasibility and safety of FFR in
patients presenting with STEMI and MVD.
Study design
A prospective, non-randomized, longitudinal study. Investigator driven.
Study burden and risks
As with any invasive coronary procedure the risks of a PCI procedure include;
bleeding, perforation of a coronary vessel, infarct extension, and arrhythmias.
Current used FFR wires have comparable safety profiles as standard angioplasty
wires. In the largest trial to date, usage of FFR was not associated with
prolongation of the interventional procedure nor with more usage of contrast
agent as compared with the normal angiography group.
Hanzeplein 1
PO Box 30 0001 9700 RB Groningen
Nederland
Hanzeplein 1
PO Box 30 0001 9700 RB Groningen
Nederland
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL33668.042.10 |