Early Versus Delayed Timing of Intervention in Patients With Acute Coronary Syndromes (TIMACS)

Population Health Research Institute (PHRI)

Status: Completed

Conditions: Unstable Angina; Myocardial Infarction

Treatments: Procedure: Delayed Coronary Intervention; Procedure: Early Coronary Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT00552513

FRN: MCT-79654

ISRCTN20993046 (Registry Identifier)

Details and patient eligibility

About

The timing of intervention study is a prospective, randomized, international, multicentre comparison of the relative efficacy, safety, and cost effectiveness of a management strategy of coronary angiography and intervention performed within 24 hours of randomization versus delayed coronary angiography and intervention in patients after 36 hours with acute coronary syndromes (ACS).

Enrollment: 3,031 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients presenting or admitted to hospital with symptoms suspected to represent an acute coronary syndrome (unstable angina or MI without persistent ST elevation) i.e., clinical history consistent with new onset, or a worsening pattern, of characteristic ischemic chest pain or ischemic symptoms occurring at rest or with minimal activity (lasting longer than five minutes or requiring sublingual nitroglycerin for relief of the pain)

2. Able to randomise within 24 hours of the onset of the most recent episode of symptoms

3. At least two of the three following additional criteria:

   • Age more than or equal to 60 years
   • Troponin T or I or Creatine Kinase - Myocardial Bands (CK-MB) above the upper limit of normal for the local institution
   • ElectroCardioGram (ECG) changes compatible with ischemia (i.e., ST depression at least 1 mm in two contiguous leads or T wave inversion mroe than 3 mm or any dynamic ST shift or transient ST elevation)

4. Written informed consent dated and signed

Exclusion criteria

1. Age less than 21 years
2. Not a suitable candidate for revascularisation
3. Co-morbid condition with life expectancy less than six months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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3,031 participants in 2 patient groups

Early Coronary Intervention

Other group

Description:

Coronary angiography and intervention (either percutaneous coronary intervention \[PCI\] or coronary artery bypass graft \[CABG\] surgery) as soon as possible (within 24 hours of randomisation).

Treatment:

Procedure: Early Coronary Intervention

Delayed Coronary Intervention

Other group

Description:

Delayed intervention: Coronary angiography and intervention (either percutaneous coronary intervention \[PCI\] or coronary artery bypass graft \[CABG\] surgery) any time after 36 hours after randomisation.

Treatment:

Procedure: Delayed Coronary Intervention