Acute Coronary SyndromeHDL_ACSNCT01278875
Function of High Density Lipoproteins in Acute Coronary Syndromes
An observational study of Acute Coronary Syndrome, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Coronary Syndrome
- How many people
- 65 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2011to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients presenting to hospital with an acute coronary syndrome, within 72 hours
Who may be able to join
- Men and women 18-80 years of age
- Acute Coronary Syndrome within 72 hours of presentation
- Elevated tropinins (T or I)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High Density Lipoprotein Function in Acute Coronary Syndromes
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.
Read the 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.
- Conditions
- Acute Coronary Syndrome
- Keywords
- High density lipoproteins, Acute coronary syndromes, Cellular cholesterol efflux, HDL: proteomics, Nitric Acid production
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Acute Coronary Syndrome | Subjects with ACS within 72 hours of clinical presentation | |
| Stable CAD subjects | Patients with stable, chronic CAD | |
| Control subjects | Healthy individuals |
What is being measured
The primary outcome is the main question the study is designed to answer.
HDL-mediated cellular cholesterol efflux
Biomarkers of HDL function
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- McGill University
- Responsible party
- Principal investigator, Jacques Genest, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Jacques Genest, MD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01278875
- Sponsor's protocol ID
- 10-208-BMA
- Acronym
- HDL_ACS
- Status last verified
- Oct 2023
- First submitted
- 18 Jan 2011
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Density Lipoprotein Function in Acute Coronary Syndromes
- ClinicalTrials.gov ID
- NCT01278875
- Acronym / sponsor ID
- HDL_ACS / 10-208-BMA
- Conditions
- Acute Coronary Syndrome
- Keywords
- High density lipoproteins, Acute coronary syndromes, Cellular cholesterol efflux, HDL: proteomics, Nitric Acid production
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- McGill University
- Study start
- Jan 2011
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 19 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acute Coronary Syndrome | – | –Subjects with ACS within 72 hours of clinical presentation |
| Stable CAD subjects | – | –Patients with stable, chronic CAD |
| Control subjects | – | –Healthy individuals |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting to hospital with an acute coronary syndrome, within 72 hours
Key inclusion criteria (3 listed)
- Men and women 18-80 years of age
- Acute Coronary Syndrome within 72 hours of presentation
- Elevated tropinins (T or I)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
HDL-mediated cellular cholesterol efflux
Time frame: 12 weeks
Biomarkers of HDL function
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacques Genest, MD principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HDL-mediated cellular cholesterol efflux (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.