Coronary Heart DiseaseNCT00139958
Prognosis of Acute Coronary Syndrome in HIV-infected Patients
An observational study of Coronary Heart Disease and HIV Infection, run by Saint Antoine University Hospital at 1 site in France.
Trial summary
Objectives: Evaluate differences for mortality, morbidity and the cardiovascular risk factors between HIV and non-HIV patients with an acute coronary syndromes (ACS) after a 3-years follow up. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Heart Disease, HIV Infection
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2003to Jul 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: PAtients with de novo acute coronary syndromes age > 18years old.
Who may be able to join
- Patients > 18 year's old
- Man or woman HIV-infected for HIV 1 with or without highly active antiretroviral therapy
- Acute coronary syndromes (STEMI, NSTEMI and unstable angina)
Who cannot join
- Known atherosclerotic artery disease (MI, ACS, PCI, CABG, coronary stenosis, stroke, peripheral arteriopathy)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prognosis After Acute Coronary Syndrome in HIV-infected Patients
Objectives: Evaluate differences for mortality, morbidity and the cardiovascular risk factors between HIV and non-HIV patients with an acute coronary syndromes (ACS) after a 3-years follow up.
Read the detailed description
Background: There have been many cases of myocardial infarction reported in HIV-infected young adults treated with HAART. Little is known to date, concerning the outcome and prognostic factors of patients with acute coronary syndrome and HIV-infection.
Methods: Prospective cohort study to compare the evolution and prognosis between HIV and non-HIV patients with an ACS.
Duration of the study: Two years for including patients. Three years of follow-up 100 HIV-patients with ACS and 200 non-HIV patients with ACS will be included in the study. All patients will be included in the study from 30 Intensive Care Unit of Cardiology departments in France.
Results: To compare the incidence of total mortality, cardiovascular mortality (myocardial infarction, sudden death, cardiogenic shock, fatal stroke), morbidity (non fatal myocardial infarction, unstable angina, recurrence of ischemia, cardiac failure, non fatal stroke) and revascularization (percutaneous coronary intervention, coronary artery bypass graft surgery) during a 3-year follow-up between HIV and non-HIV patients with ACS. Univariate and multivariate analysis of predictive factors for cardiovascular events will be done.
- Conditions
- Coronary Heart Disease, HIV Infection
- Keywords
- Acute coronary syndrome, HIV infection, Prognosis, Coronary heart disease, Revascularization
- Medical subject headings
- Coronary Disease, HIV Infections, 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 |
|---|---|---|
| 1 | Not described | |
| 2 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the rate of Major Adverse Cardiac and Cerebrovascular Events between HIV+ and HIV- after a first episode of ACS after a 3-years follow up.
Measured: 36 months
Secondary outcomes (1)
Clinical, angiographic characteristics at baseline and comparison between HIV+ and HIV-
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2005 (estimated)
- Study startNov 2003
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- 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
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint Antoine University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Ariel Cohen, MD, PhD, Study chair, Saint Antoine University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00139958
- Sponsor's protocol ID
- PACS
- Status last verified
- May 2010
- First submitted
- 29 Aug 2005
- Last updated
- 28 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Robert R, Cottin Y, Potard V, Mary-Krause M, Lang S, Teiger E, Collet JP, Chauvet-Droit M, Ederhy S, Soulat-Dufour L, Ancedy Y, Adavane-Scheuble S, Nhan P, Steg PG, Funck-Brentano C, Costagliola D, Cohen A, Boccara F; on behalf the PACS-HIV Investigators. Coronary Angiographic Features and Major Adverse Cardiac or Cerebrovascular Events in People Living With Human Immunodeficiency Virus Presenting With Acute Coronary Syndrome. Circ Cardiovasc Interv. 2022 Jun;15(6):e011945. doi: 10.1161/CIRCINTERVENTIONS.122.011945. Epub 2022 May 10. No abstract available.
PubMed 35535605Boccara F, Mary-Krause M, Potard V, Teiger E, Lang S, Hammoudi N, Chauvet M, Ederhy S, Dufour-Soulat L, Ancedy Y, Nhan P, Adavane S, Steg PG, Funck-Brentano C, Costagliola D, Cohen A; PACS-HIV (Prognosis of Acute Coronary Syndrome in HIV-Infected Patients) Investigators dagger. HIV Infection and Long-Term Residual Cardiovascular Risk After Acute Coronary Syndrome. J Am Heart Assoc. 2020 Sep;9(17):e017578. doi: 10.1161/JAHA.119.017578. Epub 2020 Aug 26.
PubMed 32844734
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognosis After Acute Coronary Syndrome in HIV-infected Patients
- ClinicalTrials.gov ID
- NCT00139958
- Acronym / sponsor ID
- PACS
- Conditions
- Coronary Heart Disease, HIV Infection
- Keywords
- Acute coronary syndrome, HIV infection, Prognosis, Coronary heart disease, Revascularization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Saint Antoine University HospitalUniversity, hospital or other
- Study start
- Nov 2003
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 31 Aug 2005 (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.
Objectives: Evaluate differences for mortality, morbidity and the cardiovascular risk factors between HIV and non-HIV patients with an acute coronary syndromes (ACS) after a 3-years follow up.
Detailed description
Background: There have been many cases of myocardial infarction reported in HIV-infected young adults treated with HAART. Little is known to date, concerning the outcome and prognostic factors of patients with acute coronary syndrome and HIV-infection.
Methods: Prospective cohort study to compare the evolution and prognosis between HIV and non-HIV patients with an ACS.
Duration of the study: Two years for including patients. Three years of follow-up 100 HIV-patients with ACS and 200 non-HIV patients with ACS will be included in the study. All patients will be included in the study from 30 Intensive Care Unit of Cardiology departments in France.
Results: To compare the incidence of total mortality, cardiovascular mortality (myocardial infarction, sudden death, cardiogenic shock, fatal stroke), morbidity (non fatal myocardial infarction, unstable angina, recurrence of ischemia, cardiac failure, non fatal stroke) and revascularization (percutaneous coronary intervention, coronary artery bypass graft surgery) during a 3-year follow-up between HIV and non-HIV patients with ACS. Univariate and multivariate analysis of predictive factors for cardiovascular events will be done.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | – |
| 2 | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- PAtients with de novo acute coronary syndromes age > 18years old.
Key inclusion criteria (3 listed)
- Patients > 18 year's old
- Man or woman HIV-infected for HIV 1 with or without highly active antiretroviral therapy
- Acute coronary syndromes (STEMI, NSTEMI and unstable angina)
Key exclusion criteria (1 listed)
- Known atherosclerotic artery disease (MI, ACS, PCI, CABG, coronary stenosis, stroke, peripheral arteriopathy)
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
Comparison of the rate of Major Adverse Cardiac and Cerebrovascular Events between HIV+ and HIV- after a first episode of ACS after a 3-years follow up.
Time frame: 36 months
1 secondary outcome
Clinical, angiographic characteristics at baseline and comparison between HIV+ and HIV-
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2010.
- Derived from this study: PubMed 35535605Robert R, Cottin Y, Potard V, Mary-Krause M, Lang S, Teiger E, Collet JP, Chauvet-Droit M, Ederhy S, Soulat-Dufour L, Ancedy Y, Adavane-Scheuble S, Nhan P, Steg PG, Funck-Brentano C, Costagliola D, Cohen A, Boccara F; on behalf the PACS-HIV Investigators. Coronary Angiographic Features and Major Adverse Cardiac or Cerebrovascular Events in People Living With Human Immunodeficiency Virus Presenting With Acute Coronary Syndrome. Circ Cardiovasc Interv. 2022 Jun;15(6):e011945. doi: 10.1161/CIRCINTERVENTIONS.122.011945. Epub 2022 May 10. No abstract available.
- Derived from this study: PubMed 32844734Boccara F, Mary-Krause M, Potard V, Teiger E, Lang S, Hammoudi N, Chauvet M, Ederhy S, Dufour-Soulat L, Ancedy Y, Nhan P, Adavane S, Steg PG, Funck-Brentano C, Costagliola D, Cohen A; PACS-HIV (Prognosis of Acute Coronary Syndrome in HIV-Infected Patients) Investigators dagger. HIV Infection and Long-Term Residual Cardiovascular Risk After Acute Coronary Syndrome. J Am Heart Assoc. 2020 Sep;9(17):e017578. doi: 10.1161/JAHA.119.017578. Epub 2020 Aug 26.
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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.
Ariel Cohen, MD, PhD study chair
Saint Antoine University Hospital
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 Coronary Heart Disease and HIV Infection, run by Saint Antoine University Hospital at 1 site in France.
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 1 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: finished, as of the sponsor's last update on 28 Jul 2010. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Comparison of the rate of Major Adverse Cardiac and Cerebrovascular Events between HIV+ and HIV- after a first episode of ACS after a 3-years follow up. (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00139958, which also lists 2 linked publications.
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 28 Jul 2010.