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

April 19, 2022 updated by: Population Health Research Institute

An International Randomised Trial of Early Versus Delayed Invasive Strategies in Patients With Non-ST Segment Elevation Acute Coronary Syndromes

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3031

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
        • Hamilton Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Early Coronary Intervention
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).
Procedure: Early Coronary Intervention
Perform coronary angiography and intervention (either percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG] surgery) as soon as possible (and within 24 hours of randomisation).
Other: Delayed Coronary Intervention
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.
Procedure: Delayed Coronary Intervention
Perform coronary angiography and intervention (either percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG] surgery) any time after 36 hours after randomisation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Composite of Death, Myocardial (re-) Infarction, or Stroke
Time Frame: 180 days
180 days

Secondary Outcome Measures

Outcome Measure
Time Frame
First Occurrence of Any Component of the Composite of Death, MI, or Refractory Ischemia
Time Frame: 180 days
180 days
Composite of Death, MI, Stroke, Refractory Ischemia or Repeat Revascularization at 180 Days
Time Frame: 180 days
180 days
Stroke at 30 Days and 180 Days
Time Frame: 180 days
180 days
Need for Mechanical or Pharmacological Coronary Revascularization (i.e. Thrombolysis, PCI, CABG) at Days 30, 90, and 180
Time Frame: 180 days
180 days
In-hospital Major Bleeding
Time Frame: Hospital discharge
Hospital discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Population Health Research Institute

Collaborators

Canadian Institutes of Health Research (CIHR)
Hamilton Health Sciences Corporation

Investigators

  • Principal Investigator: Shamir Mehta, MD, MSc, Population Health Research Institute, Hamilton Health Sciences, McMaster University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

October 30, 2007

First Submitted That Met QC Criteria

November 1, 2007

First Posted (Estimate)

November 2, 2007

Study Record Updates

Last Update Posted (Actual)

April 21, 2022

Last Update Submitted That Met QC Criteria

April 19, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FRN: MCT-79654
  • ISRCTN20993046 (Registry Identifier: International Standard Randomised Controlled Trial Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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