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

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ClinicalTrials.gov Identifier: NCT00552513
Recruitment Status : Completed
First Posted : November 2, 2007
Results First Posted : June 27, 2014
Last Update Posted : June 27, 2014
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Hamilton Health Sciences Corporation
Information provided by (Responsible Party):
Population Health Research Institute

Brief Summary:
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 or disease Intervention/treatment Phase
Unstable Angina Myocardial Infarction Procedure: Early Coronary Intervention Procedure: Delayed Coronary Intervention Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3031 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : May 2005
Actual Primary Completion Date : July 2008
Actual Study Completion Date : February 2009

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Composite of Death, Myocardial (re-) Infarction, or Stroke [ Time Frame: 180 days ]

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


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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Publications of Results:
Other Publications:
Responsible Party: Population Health Research Institute
ClinicalTrials.gov Identifier: NCT00552513     History of Changes
Other Study ID Numbers: FRN: MCT-79654
ISRCTN20993046 ( Registry Identifier: International Standard Randomised Controlled Trial Number )
First Posted: November 2, 2007    Key Record Dates
Results First Posted: June 27, 2014
Last Update Posted: June 27, 2014
Last Verified: May 2014

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

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