Acute Coronary SyndromeMAVASCORNCT02857387
Markers of Vascular Aging and Coronary Syndrome
A study testing blood sample withdrawn in people with Acute Coronary Syndrome, run by CHU de Reims at 1 site in France.
Trial summary
Atherosclerosis and aging are associated to the raise of biochemical alterations of proteins grouped under the name of " non-enzymatic post-translational modifications ". They often correspond to the irreversible binding of glucose or other oses (glycation) or urea derivatives (carbamylation) on proteins and lead to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- blood sample withdrawn
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2015to 27 Aug 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- acute coronary heart syndrome
- included during hospitalization, usual cardiologic follow-up planned in Reims university hospital
Who cannot join
- <18yo
Trial locations and contacts
1 site in 1 country.
About this study
Atherosclerosis and aging are associated to the raise of biochemical alterations of proteins grouped under the name of " non-enzymatic post-translational modifications ". They often correspond to the irreversible binding of glucose or other oses (glycation) or urea derivatives (carbamylation) on proteins and lead to the formation of complex compounds (post-translational modifications derived products, PTMD) that can accumulate in tissues and be responsible for deleterious effects. The specific role of these compounds in the pathophysiology of aging and atherosclerosis remains unknown, as are the molecular and cellular mechanisms implicated.
This project is based on the hypothesis that non-enzymatic post-translational modifications may cause changes in the genesis of complication of coronary atherosclerosis and that PTMD could therefore constitute relevant biomarkers in this specific clinical situation.
Read more
To explore these potential new biomarkers, the investigators designed a study in patients having experienced an acute coronary syndrome and followed during a year. The concentrations of PTMD assayed at 0, 1, 3, 12 months, will be correlated to clinical (severity and evolution) and paraclinical (cutaneous autofluorescence) data and the effect of cardiac rehabilitation will be assessed.
This should help to identify new (and non-traditional) biomarkers of coronary heart disease and determine some of the implicated pathophysiological mechanisms.
- Conditions
- Acute Coronary Syndrome
- Being tested
- blood sample withdrawn
- 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.
blood sample withdrawnBiological
| Study group | Role | What they receive |
|---|---|---|
| acute coronary syndrome | Experimental | Not described Receives: Biological: blood sample withdrawn |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-translational modifications of Proteins quantification assessed by Liquid chromatography-mass spectrometry
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2016 (estimated)
- Study startOct 2015
- Primary completion27 Aug 2018
- Study completion27 Aug 2018
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 CHU de ReimsThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02857387
- Sponsor's protocol ID
- PO15043
- Acronym
- MAVASCOR
- Status last verified
- Oct 2018
- First submitted
- 29 Jul 2016
- Last updated
- 25 Oct 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Markers of Vascular Aging and Coronary Syndrome
- ClinicalTrials.gov ID
- NCT02857387
- Acronym / sponsor ID
- MAVASCOR / PO15043
- Conditions
- Acute Coronary Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- Oct 2015 (actual)
- Primary completion
- 27 Aug 2018 (actual)
- Study completion
- 27 Aug 2018 (actual)
- First posted
- 5 Aug 2016 (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.
Atherosclerosis and aging are associated to the raise of biochemical alterations of proteins grouped under the name of " non-enzymatic post-translational modifications ". They often correspond to the irreversible binding of glucose or other oses (glycation) or urea derivatives (carbamylation) on proteins and lead to the formation of complex compounds (post-translational modifications derived products, PTMD) that can accumulate in tissues and be responsible for deleterious effects. The specific role of these compounds in the pathophysiology of aging and atherosclerosis remains unknown, as are the molecular and cellular mechanisms implicated.
This project is based on the hypothesis that non-enzymatic post-translational modifications may cause changes in the genesis of complication of coronary atherosclerosis and that PTMD could therefore constitute relevant biomarkers in this specific clinical situation.
To explore these potential new biomarkers, the investigators designed a study in patients having experienced an acute coronary syndrome and followed during a year. The concentrations of PTMD assayed at 0, 1, 3, 12 months, will be correlated to clinical (severity and evolution) and paraclinical (cutaneous autofluorescence) data and the effect of cardiac rehabilitation will be assessed.
This should help to identify new (and non-traditional) biomarkers of coronary heart disease and determine some of the implicated pathophysiological mechanisms.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| acute coronary syndrome | Experimental | Biological: blood sample withdrawn |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- acute coronary heart syndrome
- included during hospitalization, usual cardiologic follow-up planned in Reims university hospital
Key exclusion criteria (1 listed)
- <18yo
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 |
|---|---|---|
| blood sample withdrawn | Biological | acute coronary syndrome |
Primary outcome
Post-translational modifications of Proteins quantification assessed by Liquid chromatography-mass spectrometry
Time frame: up to 1 year
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 25 Oct 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood sample withdrawn in people with Acute Coronary Syndrome, run by CHU de Reims 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 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 25 Oct 2018. 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?
Post-translational modifications of Proteins quantification assessed by Liquid chromatography-mass spectrometry (time frame: up to 1 year). 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 25 Oct 2018.