The aim of this study is to investigate whether iFR-measurement of non-infarct related arteries during the acute phase of STEMI is in agreement with iFR and FFR measurement at the staged procedure.
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
iFR measurement during the acute phase in comparison to iFR measurement during
follow-up.
Secondary outcome
iFR measurement during the acute phase in comparison to FFR measurement during
follow-up.
Comparison of iFR and FFR measurement during follow-up.
Background summary
In patients with acute ST-elevation myocardial infarction, the recommended
treatment is primary percutaneous coronary intervention (PCI) of the infarct
related artery. About 40-50% of patients presenting with STEMI have
multi-vessel disease. In these patients, treatment of lesions in non-infarct
related arteries is not performed during the acute phase. Instead, complete
revascularization is achieved during a staged, follow-up procedure. Recent
studies however, have shown benefit from supplementary complete
revascularization during the acute phase.
Studies have shown that physiologic assessment is superior in estimating the
severity of lesions in comparison to angiography. The fractional flow reserve
(FFR) is a widely used diagnostic tool for physiologic assessment of coronary
lesions. However, reliable measurement of the FFR is probably not possible in
STEMI patients during the acute phase due to an decrease in maximal hyperemic
flow. The instantaneous wave free ratio (iFR) is another diagnostic tool for
physiologic assessment of lesions. In general, iFR and FFR measurements
correlate well among stable patients. It is believed that the iFR can be
measured more reliable during the acute phase of STEMI.
Study objective
The aim of this study is to investigate whether iFR-measurement of non-infarct
related arteries during the acute phase of STEMI is in agreement with iFR and
FFR measurement at the staged procedure.
Study design
This study is a multi-center, observational study. Patients can be included if
one or more lesions in the non-infarct related arteries are present which,
according to the operator, require physiologic assessment during a second
angiography. After PCI of the infarct related artery, additional measurement of
iFR will be performed during the acute phase. The measurement of iFR will be
repeated during the follow-up angiography. Moreover, measurement of FFR will
also be performed during the follow-up procedure, which will be used to guide
revascularization.
Study burden and risks
Patients participating in this study will be given the standard treatment as
per protocol and guidelines. The iFR measurements performed during the acute
phase and follow-up are expected to prolong procedural (lying in the
intervention suite) times with 5%.
Palle JuulJensens Boulevard 99
Aarhus 8200
DK
Palle JuulJensens Boulevard 99
Aarhus 8200
DK
Listed location countries
Age
Inclusion criteria
- Acute catheterization for myocardial infarction with PCI treatment of acute coronary culprit lesion
- Other coronary non*culprit stenoses that the PCI operator according to the usual clinical standards determines form an indication for follow*up CAG and is amenable for PCI
- Patient age 18 years or more
Exclusion criteria
- The clinical condition of the patient prevents informed consent
- The clinical condition of the patient indicates full revascularisation at the acute CAG (e.g.,
cardiogenic shock)
Design
Recruitment
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 | NL57292.029.16 |