|- candidate number||15346|
|- NTR Number||NTR4156|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||4-sep-2013|
|- Secondary IDs||NL 4498202913 |
|- Public Title||Timing of revascularisation in patients with transient ST segment elevation myocardial infarction|
|- Scientific Title||Timing of revascularisation in patients with transient ST segment elevation myocardial infarction|
|- hypothesis||We hypothesis that a immediate invasive strategy is superior to an delayed invasive strategy in patients with a transient ST segment elevation myocardial infarction.|
|- Healt Condition(s) or Problem(s) studied|
|- Inclusion criteria||In order to be eligible to participate in this study, a subject must meet all of the following criteria: |
- Age > 18
- 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.
- analysis in the study requires additionally that the patient can be followed for at least 12 months after the index admission.
|- Exclusion criteria||A potential subject who meets any of the following criteria will be excluded from participation in this study:|
- previous myocardial infarction
- refractory ischemia, major arrhythmias, hemodynamic instability or heart failure requiring immediate catheterization
- alternative causes of transient ST-segment elevation other than myocardial infarction.
- refusal or inability to give informed consent.
- GFR<30 ml/min.
- other contraindications for MRI
|- mec approval received||no|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-nov-2013|
|- planned closingdate||1-nov-2016|
|- Target number of participants||140|
|- Interventions||The patients will be randomized to either the immediate or delayed coronary angiography and subsequent revascularisation group|
|- 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
|- Timepoints||cardiac MRI at 4 days
cardiac MRI at 4 months|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| J. Lemkes|
|- CONTACT for SCIENTIFIC QUERIES|| J. Lemkes|
|- Sponsor/Initiator ||Initiator|
(Source(s) of Monetary or Material Support)
|- Brief summary||Rationale: 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.
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.
Study population: The research population will be recruited from the general patient population presenting through LifeNet with ST-segment elevation, and complete normalization of ST-segment elevations on admission at the coronary care unit of the hospital with PCI facilities. A total of 141 consecutive patients will be included.
Intervention (if applicable): The patients will be randomized to either the immediate or delayed coronary angiography and subsequent revascularisation group.
Main study parameters/endpoints: 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.
|- Main changes (audit trail)|
|- RECORD||4-sep-2013 - 29-sep-2013|