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Function of High Density Lipoproteins in Acute Coronary Syndromes (HDL_ACS)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2014 by Jacques Genest, McGill University Health Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01278875
First Posted: January 19, 2011
Last Update Posted: June 23, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
McGill University
Information provided by (Responsible Party):
Jacques Genest, McGill University Health Center
  Purpose
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.

Condition
Acute Coronary Syndrome

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: High Density Lipoprotein Function in Acute Coronary Syndromes

Further study details as provided by Jacques Genest, McGill University Health Center:

Primary Outcome Measures:
  • HDL-mediated cellular cholesterol efflux [ Time Frame: 12 weeks ]
    Biomarkers of HDL function


Biospecimen Retention:   Samples Without DNA
Serum Plasma HDL isolated by ultracentrifugation

Estimated Enrollment: 65
Study Start Date: January 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Acute Coronary Syndrome
Subjects with ACS within 72 hours of clinical presentation
Stable CAD subjects
Patients with stable, chronic CAD
Control subjects
Healthy individuals

Detailed Description:

High density lipoproteins (HDL) have pleiotropic effects associated with protection against atherosclerosis. These effects include cellular cholesterol efflux, anti-inflammatory and anti-oxidant effects, increase in nitric acid (NO) production from vascular endothelial cells and differentiation of endothelial progenitor cells for repair at sites of vascular injury. The measurement of the cholesterol mass within HDL (HDL-C) does not provide an adequate measure of HDL function. The investigators therefore propose to test and validate biomarkers of HDL function in patients with acute coronary syndromes (ACS).

Hypothesis: HDL lose their cardiovascular protective functions in ACS. The investigators hypothesize that these changes are transient and partly normalize within 12 weeks. In this proposal, the investigators will examine the function of HDL in acute coronary syndromes (ACS) and 12 weeks later, in the recovery phase. Acute coronary syndromes are characterized by an acute inflammatory reaction, a marked decrease in HDL in plasma and a shift of the HDL proteome to an inflammatory phenotype.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients presenting to hospital with an acute coronary syndrome, within 72 hours
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
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): NCT01278875


Contacts
Contact: Jacques Genest, MD 514 934-1934 ext 34630 jacques.genest@muhc.mcgill.ca
Contact: Colette Rondeau, RN 514 934-1934 ext 36576 colette.rondeau@muhc.mcgill.ca

Locations
Canada, Quebec
McGill University Health Centre Recruiting
Montreal, Quebec, Canada, H3A 1A1
Principal Investigator: Jacques Genest, MD         
Sub-Investigator: Luc Bilodeau, MD         
Sponsors and Collaborators
McGill University Health Center
McGill University
Investigators
Principal Investigator: Jacques Genest, MD McGill University Health Center
  More Information

Responsible Party: Jacques Genest, Professor, McGill University Health Center
ClinicalTrials.gov Identifier: NCT01278875     History of Changes
Other Study ID Numbers: 10-208-BMA
First Submitted: January 18, 2011
First Posted: January 19, 2011
Last Update Posted: June 23, 2014
Last Verified: June 2014

Keywords provided by Jacques Genest, McGill University Health Center:
High density lipoproteins
Acute coronary syndromes
Cellular cholesterol efflux
HDL: proteomics
Nitric Acid production

Additional relevant MeSH terms:
Syndrome
Acute Coronary Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases