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Completed

NCT Number: NCT02672137

Knowledge Translation for Patients With Acute Coronary Syndromes

Cluster randomized open-label experimental study multi-center of 24 hospitals to either knowledge translation vs usual care to improve care of patents hospitalized for acute coronary syndromes.

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Key information

About this study

The AMI-OPTIMA study was a cluster randomized controlled trial of 24 hospitals to one-year knowledge translation (KT) vs usual care. Prior to randomization, we reviewed charts of 100 consecutive acute coronary syndromes (ACS) patients at each participating hospital in 2009. During one year, hospitals randomized to KT completed: 1) revision of the most recent American Heart Association Guidelines of ACS management, 2) focus groups to identify and solve local care gaps, and 3)local champion team to promote evidence-based medical therapy (EBMT). At the end of 12-month of KT/usual care, we reviewed discharge prescriptions of 100 consecutive ACS patients at each participating hospital (year 2012).

EBMT was pre-defined as in-hospital anticoagulation and discharge prescription of dual anti-platelets, beta-blockers, statins, and angiotensin pathway modulating agents (for patients with impaired left ventricular systolic function). Refusal, impaired cognitive function, allergy or intolerance of patients to any of EBMT were considered valid reasons for withholding EBMT.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Had a final discharge diagnosis of one of the following categories:

  • Myocardial infarction with ST-segment elevation
  • Myocardial infarction without ST-segment elevation
  • Unstable angina
  • Acute coronary syndromes -

Exclusion criteria

  • Non-atherosclerotic coronary artery disease (as confirmed by coronary angiograms or other non-invasive tests such as stress test, coronary CT-scan, nuclear scans)
  • Hospital stay of less than 48 hours -

Treatment and study plan

knowledge translation

Behavioral

knowledge translation that include: Community of practice, local gap analysis, opinion leaders, targeted interventions, performance feedback, reminders and local formation of ACS teams.

Primary outcomes

  1. Proportion of patients who received evidence-based medical therapy at hospital discharge (mean of 4 days)

    Time frame: at hospital discharge (average of 4 days)

    Evidence-based medical therapy is defined as aspirin,dual-antiplaquelets, beta-blockers, statins.

Secondary outcomes

  1. Discharge prescription of individual evidence-based medical therapy: aspirin, dual antiplatelets, beta-blockers

    Time frame: at hospital discharge (average of 4 days)

    For each of the following medication: aspirin, dual anti-platelet, beta-blocker and statin, we calculated the proportion of patients who were prescribed the specific medication at discharge (as recorded on the discharge prescription).

  2. Safety endpoints (mortality, reinfarction, strokes and bleeding outcomes (TIMI major and minor bleeds))

    Time frame: in-hospital (average of 4 days)

    mortality, reinfarction, strokes and bleeding outcomes (TIMI major and minor bleeds)

Sponsors and collaborators

Lead sponsor

Montreal General Hospital

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)
  • Fonds de la Recherche en Santé du Québec
  • Sanofi

Registry information

Official study title

Knowledge Translation to Promote Evidence-based Medical Therapy in Acute Coronary Syndromes

Acronym: AMI-OPTIMA

Important dates

Study start
2010
Primary completion
2015
Study completion
2016
First posted
Feb 3, 2016
Registry last updated
Feb 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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