Acute Coronary SyndromeNCT04904432
PLIN1 Variants in Precocious ACS (SCAPLIN)
A study testing PLIN1 gene sequencing in people with Acute Coronary Syndrome, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
This study aims to identify a genetic predisposition factor of precocious acute coronary syndrome occurrence (ACS). ACS is a major public health problem and the first cause of mortality in the world. It can be due to several risk factor such as heredity. Read more about this study
- Who is it for?
- Ages 10 to 55 years
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- PLIN1 gene sequencing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 15 Sep 2021to 1 Jun 2024
- Phase
- Interventional
- 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 10 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age of the patient when ACS occurs (between 18 and 50yo for men, between 18 and 55yo for women)
- Written informed consent
Who cannot join
- Men <18yo or >50yo
- Women <18yo or >55yo
- ACS causes (toxic, coronary dissection)
- Congenital cardiac malformations
- Familial hypercholesterolaemia
- Pregnancy, breast-feeding women or vulnerable profile.
- Patient refusal to participate or previously included in a clinical research trial.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Assistance Publique Hôpitaux de Marseille
Marseille, 13005
Nathalie BONELLO-PALOT, Pharm.D, PhD
Laurent BONELLO, MD, PhD
About this study
Official title: Involvement of Perilipin-1 Variants in Precocious Acute Coronary Syndrome
This study aims to identify a genetic predisposition factor of precocious acute coronary syndrome occurrence (ACS). ACS is a major public health problem and the first cause of mortality in the world. It can be due to several risk factor such as heredity. the investigators make the hypothesis that occurrence of early ACS (defined as <50yo for men and <55yo for women) could be the initiatory event of a mild form of genetic lipodystrophy . Our previous study shown an occurrence risk of ACS about 8.3 in patients carrying a mutation in the PLIN1 gene versus patients without a mutation. The PLIN1 gene encode for perilipin 1 protein localized on the lipid droplet surface. This protein phosphorylation activates the triglycerides lipolysis. Our goals in this study are multiple: to validate the high frequency of mutations in this gene in patients with early ACS, to determine differences in triglycerides metabolism and also relapse rate between carrier and non-carrier patients of mutation in PLIN1. Our first aim will be to carry out the inclusion of 200 patients with precocious ACS. This will allow us to obtain around 15 patients carrying a mutation in the PLIN1 gene based on our previous study. the investigators will reprogramme patients' cells (carrying or not a PLIN1 mutation) in human Induce Pluripotent Stem cells (hIPSc). These hIPSc will be differentiated in cell types of interest as adipocytes or macrophages. the investigators will then study triglycerides metabolism (lipid droplet formation, localization and phosphorylation of perlipin 1) in these cells and atheroma plaque formation. Finally, the investigators will study clinical data such as relapse rate and searching for correlation with PLIN1 mutation.
- Conditions
- Acute Coronary Syndrome
- Being tested
- PLIN1 gene sequencing
- 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.
PLIN1 gene sequencingGenetic
One supplementary blood sample will be taken (compare to classical ACS treatment and follow up) to realize genetic analyse of PLIN1 gene, looking for mutations
| Study group | Role | What they receive |
|---|---|---|
| young ACS patients | Other | Not described Receives: Genetic: PLIN1 gene sequencing |
What is being measured
The primary outcome is the main question the study is designed to answer.
PLIN1 mutation
sequencing PLIN1 gene to look for mutation
Measured: 1 month
Lipid droplets
Analyze size of lipid droplets in differentiated hIPS cells
Measured: 3 years
Secondary outcomes (1)
relapse rate
Ischaemic relapse rate during the year of classical following-up
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start15 Sep 2021
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Jun 2024 (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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emilie GARRIDO-PRADALIE, Study director, Assistance Publique Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04904432
- Sponsor's protocol ID
- 2021-06
- Status last verified
- Oct 2022
- First submitted
- 15 Apr 2021
- Last updated
- 27 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Involvement of Perilipin-1 Variants in Precocious Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT04904432
- Acronym / sponsor ID
- 2021-06
- Conditions
- Acute Coronary Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 27 May 2021 (actual)
- 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.
This study aims to identify a genetic predisposition factor of precocious acute coronary syndrome occurrence (ACS). ACS is a major public health problem and the first cause of mortality in the world. It can be due to several risk factor such as heredity. the investigators make the hypothesis that occurrence of early ACS (defined as <50yo for men and <55yo for women) could be the initiatory event of a mild form of genetic lipodystrophy . Our previous study shown an occurrence risk of ACS about 8.3 in patients carrying a mutation in the PLIN1 gene versus patients without a mutation. The PLIN1 gene encode for perilipin 1 protein localized on the lipid droplet surface. This protein phosphorylation activates the triglycerides lipolysis. Our goals in this study are multiple: to validate the high frequency of mutations in this gene in patients with early ACS, to determine differences in triglycerides metabolism and also relapse rate between carrier and non-carrier patients of mutation in PLIN1. Our first aim will be to carry out the inclusion of 200 patients with precocious ACS. This will allow us to obtain around 15 patients carrying a mutation in the PLIN1 gene based on our previous study. the investigators will reprogramme patients' cells (carrying or not a PLIN1 mutation) in human Induce Pluripotent Stem cells (hIPSc). These hIPSc will be differentiated in cell types of interest as adipocytes or macrophages. the investigators will then study triglycerides metabolism (lipid droplet formation, localization and phosphorylation of perlipin 1) in these cells and atheroma plaque formation. Finally, the investigators will study clinical data such as relapse rate and searching for correlation with PLIN1 mutation.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| young ACS patients | Other | Genetic: PLIN1 gene sequencing |
Who may qualify
- Ages
- 10 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Age of the patient when ACS occurs (between 18 and 50yo for men, between 18 and 55yo for women)
- Written informed consent
Key exclusion criteria (7 listed)
- Men <18yo or >50yo
- Women <18yo or >55yo
- ACS causes (toxic, coronary dissection)
- Congenital cardiac malformations
- Familial hypercholesterolaemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PLIN1 gene sequencingOne supplementary blood sample will be taken (compare to classical ACS treatment and follow up) to realize genetic analyse of PLIN1 gene, looking for mutations | Genetic | young ACS patients |
Primary outcome
PLIN1 mutation
Time frame: 1 month
sequencing PLIN1 gene to look for mutation
Lipid droplets
Time frame: 3 years
Analyze size of lipid droplets in differentiated hIPS cells
1 secondary outcome
relapse rate
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2022.
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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.
Emilie GARRIDO-PRADALIE study director
Assistance Publique Hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PLIN1 gene sequencing in people with Acute Coronary Syndrome, run by Assistance Publique Hopitaux De Marseille 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 2 inclusion and 7 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 27 Oct 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nathalie BONELLO-PALOT (04 91 38 77 87 ext. +33, nathalie.bonello@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PLIN1 mutation (time frame: 1 month). The study lists 2 primary outcomes in all. 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 27 Oct 2022.