Function of High Density Lipoproteins in Acute Coronary Syndromes

Acute Coronary Syndrome Clinical Trial

— HDL_ACS  

Official title:

High Density Lipoprotein Function in Acute Coronary Syndromes

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01278875
• Other study ID #: 10-208-BMA
• Status: Active, not recruiting
• Start date: January 2011
• Est. completion date: December 2025

Study information

• Verified date: October 2023
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 65
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Locations

Country	Name	City	State
Canada	McGill University Health Centre	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
McGill University Health Centre/Research Institute of the McGill University Health Centre	McGill University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HDL-mediated cellular cholesterol efflux	Biomarkers of HDL function	12 weeks