To assess the clinical outcome in NSTEMI and STEMI patients with vulnerable plaque characteristics in non-culprit vessels as assessed by OCT.
ID
Source
Brief title
Condition
- Coronary artery disorders
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
A composite of major adverse cardiovascular events (all-cause mortality,
non-fatal myocardial infarction (STEMI or NSTEMI), or unplanned
revascularization) at 2 year follow-up.
Secondary outcome
The primary outcome at 1 and 5 year follow-up. Also target lesion/vessel
failure and target lesion/vessel revascularisation at 1,2, and 5 years.
Background summary
Recently, major advances in the treatment of acute coronary syndromes have been
made, but still there is a large proportion of patients at risk for new
coronary events after experiencing ACS. These new events can be largely
attributed to residual vulnerable lesions. Possible detection of vulnerable
lesions by means of OCT imaging may help to determine which lesions need
additional treatment in order to reduce adverse cardiac events.
Study objective
To assess the clinical outcome in NSTEMI and STEMI patients with vulnerable
plaque characteristics in non-culprit vessels as assessed by OCT.
Study design
This is a multicenter, prospective cohort, clinical trial. After PCI for
myocardial infarction (STEMI or NSTEMI), patients with residual,
hemodynamically non-obstructive plaque will be analyzed for plaque morphology
and vulnerability by means of OCT. Structured clinical follow-up will be
performed at 1, 2 and 5 years. Primary analysis wil be performed at 2 years
follow-up.
Study burden and risks
Patiënts included in the trial will undergo OCT imaging to assess plaque
morphology and vulnerability. Patients are exposed to radiation as part of the
invasive coronary angiography and fractional flow reserve (FFR) measurement
which is clinically indicated. The procedural risks of intracoronary imaging
are below 1%. An extra blood sample will be taken. Patient will be followed by
telephonic follow-up, 3 times during the study, which will take about 10
minutes each. The expected benefit is a structured clnical follow-up at 1, 2
and 5 years.
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
Inclusion criteria for the main trial:
- Informed consent must be obtained.
- Patients are hospitalized with a STEMI or NSTEMI (or have been in the last 6
weeks), for which they are subjected to invasive coronary angiography.
- Invasive coronary angiography shows residual non-culprit CAD (target
lesion(s))
- Patient has >= 1 target lesion(s) on angiography with following additional
characteristics:
- Lesion has visual stenosis of 30-90%.
- Lesion is non-obstructive (FFR>0.80).
- Lesion is not in-stent restenosis.
Inclusion criteria for the registry:
Inclusion criteria for the registry are the same as for the main trial, except:
- All target lesions are obstructive (FFR<=0.80).
Exclusion criteria
- Refusal or inability to provide informed consent.
- < 18 years of age
- Hemodynamic instability, respiratory failure, or Killip class >= 3 at time of
inclusion.
- Previous CABG.
- Indication for revascularization by CABG.
- Anatomy of target lesion(s) unsuitable for OCT catheter crossing or imaging
(aorta-ostial lesions, too small diameter segment, severe calcifications,
chronic total occlusion, lesions located to distally)
- Pregnancy.
- Estimated life expectancy < 3 year
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 |
|---|---|
| ClinicalTrials.gov | NCT03857971 |
| CCMO | NL67426.091.18 |