North American Acute Coronary Syndrome (ACS) Reflective III Pilot

NCT03994575 | Completed

• 1 other identifier: DCV-2017-11935
• Study Type: observational
• Target: 248
• Locations: 1 country
• Sites: 1

Brief Summary

The North American ACS Reflective III Pilot is an observational, Quality Enhancement Research Initiative (QuERI), knowledge translation program designed to give feedback to physicians on their post-ACS lipid-lowering management in an effort to support their decision-making and choice of therapies and thereby better achieve evidence-based, guideline-recommended management of post-ACS patients. The ACS Reflective III Pilot follows the completed ACS Registries I, II, and III, ACS Reflective I, and the ongoing ACS Reflective II programs.

Conditions

Dyslipidemias; Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

• Proportion of patients achieving Canadian and American guideline-recommended LDL-cholesterol goal(s)

  The primary endpoint is the proportion of patients achieving Canadian and American guideline-recommended goals (i.e., LDL-C ≤1.8 mmol/L \[70 mg/dL\] or \>50% LDL-C reduction, respectively, after the final visit (Visit 3; approximately 1 year post-ACS). (If, during the course of the study, the guideline-recommended LDL-C goal changes, both the current and new goals will be considered).

  12 months

Secondary Outcomes (3)

• Relative reduction of LDL-C achieved

  3-6 and 6-12 months, respectively

• Proportion of patients achieving guideline-recommended targets

  3-6 months

• Proportion of patients receiving additional lipid-modifying therapies (including PCSK9 inhibition)

  3-6 and 6-12 months, respectively

Interventions

Guideline recommended feedback OTHER

The ACS Reflective III Pilot program is a quality assurance program where the decision to follow the recommendations and all treatment decisions related to patient care are left to the physician's discretion and feedback to the physician with their aggregate and individual patient data is intended as a quality assurance undertaking

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients age 18 years or older, 1-12 months post-ACS, with LDL-C ≥1.81 mmol/L (70 mg/dL) despite maximally tolerated statin ± ezetimibe therapy (including patients who are intolerant of ≥2 statins).

You may qualify if:

• Patients ≥18 years of age;
• ACS 1-12 months prior to enrolment defined by symptoms of myocardial ischemia with an unstable pattern, occurring at rest or with minimal exertion, within 72 hours of an unscheduled hospital admission due to presumed or proven obstructive coronary disease and at least one of the following:
• Elevated cardiac biomarkers (e.g., troponin) = myocardial infarction (MI); or,
• Resting ECG changes consistent with ischemia, plus additional evidence of obstructive coronary disease from regional wall motion or perfusion abnormality, 70% or greater epicardial coronary stenosis by angiography, or need for coronary revascularization procedure = unstable angina (UA); and,
• LDL-C ≥1.81 mmol/L (70 mg/dL) despite maximally tolerated statin ± ezetimibe therapy (including patients who are intolerant of ≥2 statins).

You may not qualify if:

• Participating in a research study where the lipid-modifying therapy is unknown, randomly assigned (i.e., choice not determined by the physician), or not approved for clinical use; or
• Follow-up or life expectancy \<1 year.

Sponsors & Collaborators

• Canadian Heart Research Centre: lead
• Sanofi: collaborator

Study Sites (1)

Canadian Heart Research Centre

Toronto, Ontario, M2J OB5, Canada

Location

MeSH Terms

Conditions

Dyslipidemias; Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Shaun G Goodman, MD, MSc

  Co-Chair, Canadian Heart Research Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: June 20, 2019
• First Posted: June 21, 2019
• Study Start: March 15, 2019
• Primary Completion: May 1, 2021
• Study Completion: May 30, 2021
• Last Updated: July 27, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)