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

This study has been completed.
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Hamilton Health Sciences Corporation
Information provided by (Responsible Party):
Population Health Research Institute
ClinicalTrials.gov Identifier:
NCT00552513
First received: October 30, 2007
Last updated: May 27, 2014
Last verified: May 2014
  Purpose

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).


Condition Intervention
Unstable Angina
Myocardial Infarction
Procedure: Early Coronary Intervention
Procedure: Delayed Coronary Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An International Randomised Trial of Early Versus Delayed Invasive Strategies in Patients With Non-ST Segment Elevation Acute Coronary Syndromes

Resource links provided by NLM:


Further study details as provided by Population Health Research Institute:

Primary Outcome Measures:
  • Composite of Death, Myocardial (re-) Infarction, or Stroke [ Time Frame: 180 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • First Occurrence of Any Component of the Composite of Death, MI, or Refractory Ischemia [ Time Frame: 180 days ] [ Designated as safety issue: No ]
  • Composite of Death, MI, Stroke, Refractory Ischemia or Repeat Revascularization at 180 Days [ Time Frame: 180 days ] [ Designated as safety issue: No ]
  • Stroke at 30 Days and 180 Days [ Time Frame: 180 days ] [ Designated as safety issue: No ]
  • Need for Mechanical or Pharmacological Coronary Revascularization (i.e. Thrombolysis, PCI, CABG) at Days 30, 90, and 180 [ Time Frame: 180 days ] [ Designated as safety issue: No ]
  • In-hospital Major Bleeding [ Time Frame: Hospital discharge ] [ Designated as safety issue: Yes ]

Enrollment: 3031
Study Start Date: May 2005
Study Completion Date: February 2009
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00552513

Locations
Canada, Ontario
Hamilton Health Sciences
Hamilton, Ontario, Canada, L8L 2X2
Sponsors and Collaborators
Population Health Research Institute
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
  More Information

Additional Information:
Publications:
Responsible Party: Population Health Research Institute
ClinicalTrials.gov Identifier: NCT00552513     History of Changes
Other Study ID Numbers: FRN: MCT-79654, ISRCTN20993046
Study First Received: October 30, 2007
Results First Received: May 27, 2014
Last Updated: May 27, 2014
Health Authority: Canada: Canadian Institutes of Health Research
Canada: Ethics Review Committee
Australia: Human Research Ethics Committee
Brazil: National Committee of Ethics in Research
Belgium: Institutional Review Board
Colombia: Institutional Review Board
Czech Republic: Ethics Committee
India: Institutional Review Board
Romania: National Medicines Agency
Thailand: Ethical Committee
United States: Institutional Review Board

Keywords provided by Population Health Research Institute:
timing
intervention
early
delayed
acute coronary syndromes
PCI
angiography
Non ST-segment elevation myocardial infarction
unstable angina
Acute Coronary Syndromes

Additional relevant MeSH terms:
Angina, Unstable
Infarction
Myocardial Infarction
Acute Coronary Syndrome
Angina Pectoris
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Ischemia
Pathologic Processes
Necrosis

ClinicalTrials.gov processed this record on August 18, 2014