NCT01278875

Brief Summary

High density lipoproteins (HDL) have many effects that protect against cardiovascular diseases. In an acute heart attack (acute coronary syndrome -ACS), HDL change in composition and structure, reflecting the inflammatory environment that accompanies an ACS. The investigators will examine the function of HDL during an ACS and again when the patient has recovered.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 19, 2011

Completed
14.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

October 10, 2023

Status Verified

October 1, 2023

Enrollment Period

14.9 years

First QC Date

January 18, 2011

Last Update Submit

October 6, 2023

Conditions

Acute Coronary Syndrome

Keywords

High density lipoproteinsAcute coronary syndromesCellular cholesterol effluxHDL: proteomicsNitric Acid production

Outcome Measures

Primary Outcomes (1)

  • HDL-mediated cellular cholesterol efflux

    Biomarkers of HDL function

    12 weeks

Study Arms (3)

Acute Coronary Syndrome

Subjects with ACS within 72 hours of clinical presentation

Stable CAD subjects

Patients with stable, chronic CAD

Control subjects

Healthy individuals

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients presenting to hospital with an acute coronary syndrome, within 72 hours

You may qualify if:

  • Men and women 18-80 years of age
  • Acute Coronary Syndrome within 72 hours of presentation
  • Elevated tropinins (T or I)

You may not qualify if:

  • Refusal to participate
  • Inability to return for a 12 week follow-up visit
  • Hemodynamic instability requiring vasopressor support, mechanical ventricular assist devices, the need for coronary artery bypass surgery
  • Lack of documented atherosclerotic CAD
  • Uncontrolled hypertension
  • Triglycerides≥5mmol/L
  • Severe obesity (BMI≥35)
  • Alcohol intake\>21 drinks/week
  • Presence of thyroid, hepatic, or renal disease
  • Autoimmune disease or any chronic or acute infectious or inflammatory illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McGill University Health Centre

Montreal, Quebec, H3A 1A1, Canada

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum Plasma HDL isolated by ultracentrifugation

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Jacques Genest, MD

    McGill University Health Centre/Research Institute of the McGill University Health Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 18, 2011

First Posted

January 19, 2011

Study Start

January 1, 2011

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

October 10, 2023

Record last verified: 2023-10

Locations

CA(1)