This study will investigate the optimal timing of coronary angiography and subsequent revascularisation in patients presenting with transient ST elevation myocardial infarction. Comparing coronary angiography and revascularisation immediately or…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary end point of the study is total infarct size as percentage of the
left ventricle at baseline CMR scan, performed 4 days after the start of
symptoms.
Secondary outcome
o The change of gadolinium-enhanced infarct size at 4 months relative to
baseline.
o The difference in the area at risk and myocardial salvage between the two
treatment groups (immediate versus delayed intervention)
o The difference in microvascular injury between the two treatment groups
(immediate versus delayed intervention).
o The change of global and regional myocardial function based on a
CMR-segmental analysis (using the 17-segments AHA model) at 4 months relative
to baseline at day 3, as measured by CMR.
o The difference in infarct size measured by troponine and CK MB as area under
the curve.
o The occurrence of recurrent ischemia requiring urgent revascularisation
during the index hospitalisation.
o Occurrence of recurrent symptomatic or asymptomatic ST-segment elevation
on continuous 12-lead ECG Holter monitor recording 24 hours after admission and
24 hours after PCI.
o The occurrence within 4 and 12 months of a Major Adverse Cardiac Event (MACE)
defined as cardiac death, myocardial infarction, coronary bypass grafting, or a
repeat percutaneous intervention of the culprit lesion.
o The presence of clinically overt heart failure at 4 and 12 months.
o The occurrence of bleeding during hospitalisation defined by the TIMI
bleeding criteria
Background summary
Patients presenting with ST-elevation myocardial infarction (STEMI), whose
symptoms and electrocardiographic changes completely resolve upon admission and
before the administration of reperfusion therapy, pose a therapeutic dilemma.
The optimal management of this syndrome, termed as transient STEMI (TSTEMI),
has not yet been fully established.
Study objective
This study will investigate the optimal timing of coronary angiography and
subsequent revascularisation in patients presenting with transient ST
elevation myocardial infarction. Comparing coronary angiography and
revascularisation immediately or pending on the GRACE score (>140, within 24
hours or <140, within 72 hours)
Study design
The study is a prospective randomized controlled, multi-centre study.
Intervention
The patients will be randomized to either the immediate or delayed coronary
angiography and subsequent revascularisation group.
Study burden and risks
One extra MRI at 4 months (60 minutes)
One extra phone interview at 1 year (15 minutes)
Approximately 5 extra venipunctures with risk of hematoma.
Boelelaan 1117
Amsterdam 1081 HV
NL
Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
- clinical presentation of an acute STEMI including chest pain and ST-segment elevations on the ECG of at least 2 mm in 2 standard limb leads or in 2 contiguous chest leads on the LifeNet ECG.
- complete normalization of ST-segment elevations and resolution of symptoms on the coronary care unit, with or without initial treatment of sublingual nitrate, heparin, P2Y12 inhibitor and/or aspirin
Exclusion criteria
- previous myocardial infarction
- refractory ischemia, major arrhythmias, hemodynamic instability or heart failure requiring immediate catheterization
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL44982.029.13 |
| OMON | NL-OMON27736 |