Timing of revascularisation in patients with transient ST segment elevation myocardial infarction

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON27736

Enrollment

140

Registered

2013-09-04

Start date

2013-11-01

Completion date

Unknown

Last updated

2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

STEMI NSTEMI Coronary angiography Revascularisation PCI Transient ST segment elevation myocardial infarction. Timing

Interventions

The patients will be randomized to either the immediate or delayed coronary angiography and subsequent revascularisation group

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

—

Contacts

Public ContactJ. Lemkes

VUmc 5F019 de Boelelaan 1117

J.lemkes@vumc.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)