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Coronary Artery DiseaseACCTHEROMANCT03034148

Platelet Acetyl Coenzyme A Carboxylase Phosphorylation in Coronary Artery Disease

A study testing Platelet Acetyl Coenzyme A Carboxylase analysis in CAD in people with Coronary Artery Disease and Acute Coronary Syndrome, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In human purified platelets, only thrombin, and not the other platelet agonists, leads to a transient activation of the protein kinase activated by AMP (AMPK) and to phosphorylation of its "bona fide" substrate, ACC on its Ser79. ACC phosphorylation (P-ACC) can be an interesting marker of thrombin action on platelets. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Platelet Acetyl Coenzyme A Carboxylase analysis in CAD
Could I receive a placebo?
No, everyone receives an active treatment
How many people
188 participants
Where
1 siteBelgium
Study dates
Mar 2015to Feb 2016
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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Signed informed consent
  • Planned angiography within the next 3 days, whatever the indication.

Who cannot join

  • Not able to sign informed consent
  • Patients on anticoagulation therapy (oral or parenteral) including heparins, fondaparinux, vitamin K antagonist, novel oral anticoagulants, for any reasons.
  • Active neoplasia
  • Active inflammatory disease
  • Patients with life expectancy lower than 3 years
  • Haemophilia and other coagulopathy
Show all 10Show fewer
  • Abnormal platelet count
  • Heart transplanted patients
  • Active hepatitis B or C or HIV patients
  • Any contra-indication for coronary angiography.

Trial locations and contacts

1 site in 1 country.

Belgium1 site
  • Cliniques Universitaires Saint Luc

    Brussels, 1200

Other trials in Belgium

About this study

Official title: Prospective Evaluation of Acetyl-Coenzyme A Carboxylase Phosphorylation State in Platelets in Atherothrombotic Coronary Artery Disease.

In human purified platelets, only thrombin, and not the other platelet agonists, leads to a transient activation of the protein kinase activated by AMP (AMPK) and to phosphorylation of its "bona fide" substrate, ACC on its Ser79. ACC phosphorylation (P-ACC) can be an interesting marker of thrombin action on platelets. Indeed platelet and coagulation interplay, though undoubtedly present in atherosclerosis and atherothrombosis, remains difficult to assess. Our group showed that atherosclerotic mice (SRBI/Apolipoprotein E knock-out) had higher platelet P-ACC compared to corresponding control mice (C57BL6). In agreement with these data, preliminary results showed increased platelet P-ACC in a small cohort of patients admitted for coronary angiogram, with demonstrated coronary artery disease (CAD).

In the light of our preliminary results, we sought to analyze platelet P-ACC in a large prospective clinical trial (ACCTHEROMA) in patients admitted for coronary angiogram. The aim of the study is to compare platelet P-ACC in platelets of patients with CAD and more particularly in unstable CAD patients to non-CAD patients. This study could potentially identify patients at high risk of future ischemic cardiovascular events, because of a higher level of thrombin generation.

Read the detailed description

Consecutive patients with planned coronary angiogram at the Cliniques Universitaires Saint Luc, Brussels, whatever the indication, will be included between March 2015 and February 2016. Informed consent will be obtained before angiogram.

  1. Blood Sampling Routine veinous blood sample will be done under fasting condition in the cardiology ward before the angiogram (standard of care for patients undergoing coronary angiogram).

In order to avoid additional puncture for blood sampling and to limit platelet activation, blood samples are withdrawn after sheath insertion at the Cath lab before any drug administration. The following measurements will be done:

  • Routine coagulation tests including international rationalize ratio, activated cephaline time, thrombin time, prothrombin time, Fibrinogen, DDimers.
  • Platelet reactivity testing by the Multiple Electrode Aggregometer (Multiplate Analysis)
  • Platelet isolation and lysates will be stocked frozen for phospho-protein analysis by immunoblotting and electrochemiluminescence (ECLIA)
  • Aliquots of poor platelet plasma stocked frozen for inflammation (HsCRP), thrombin generation tests (thrombin-antithrombin complex, prothrombin fragment F1.2, endogenous thrombin generation potential-ETP), platelet activation markers (platelet factor 4, soluble CD40ligand, soluble P-selectin) and circulating micro-RNA extraction.
  • Platelet isolation and further purification for platelet specific micro-RNA extraction.
  1. Atherosclerosis evaluation All patients underwent coronary angiogram. Significant coronary artery lesion is defined as a luminal stenosis above 50%. Syntax score will be calculated for all patients.

Global atherosclerotic plaque burden on coronary and extracoronary arteries will be evaluated by measuring calcium score on thoraco-abdominal scanner with prospective ECG-gating in a randomly selected subgroup of patients. Coronary artery calcification (CAC) is expressed as Agatston score using calcium scoring software (Philips Healthcare) with a threshold of 130 Hounsfield units. The degree of atherosclerotic burden on coronary arteries is classified as mild (Agatston score <100), moderate (Agatston score 100-400) or severe (Agatston score >400). Aortic calcification (AoC score) was measured from aortic arch to iliac arteries in all patients.

  1. Data collection Baseline characteristics of patients will be collected from the medical database of the Cliniques Universitaires Saint Luc. All coronary angiogram will be reviewed by 2 different investigators and syntax score will be calculated with the online syntax score calculator. CAC Agatston and AoC score will also be assessed by 2 different investigators.

D.Patients Classification for platelet P-ACC analysis Platelet ACC phosphorylation (P-ACC) analysis will be done by immunoblotting with a specific antibody probing for phosphorylated (Ser 79) ACC. Purified washed platelets stimulated with 0.5 units/ml thrombin will be used as positive internal controls.

Patients will first be classified in non-CAD and CAD groups based on the results of coronary angiogram and CAC Agatston score: Non-CAD (absence of lesion on angiogram and/or CAC Agatston score<100) and CAD (presence of at least 1 lesion on angiogram and/or CAC Agatston score>100).

In a second analysis, based on clinical presentation, the CAD group will further be divided into Stable CAD or Unstable CAD [acute coronary syndrome (ACS)]. Platelet P-ACC will be compared in both subgroups. This detailed classification will outline high-risk patients with ongoing acute coronary syndrome.

  1. Sample size and statistical analysis. Based on our preliminary data, we determined that enrolment of 102 patients would provide a power of 80% at a significance level of 5% to detect a difference of 0.15 (A.U.) in the phosphorylation of ACC in atherosclerotic patients, compared to non CAD patients.

Continuous variables will be expressed as mean +/- one standard deviation, categoric variables as counts and percentages. Patients will separated in four groups depending on the level of P-ACC (quartiles). Clinical presentation, thrombin generation markers and calcium scoring will be compared in all these groups, based on ANOVA analysis. Variables will be submitted to logistic regression test in order to identify independent predictors of high ACC phosphorylation state. The role of high platelets P-ACC in assessing the risk of the patients will be then studied.

F.Follow-up A follow-up period of 3 years is planned. Events recorded during the follow-up period will be obtained from the medical database and a phone call will be done in case of missing data.

Being tested
Platelet Acetyl Coenzyme A Carboxylase analysis in CAD
Keywords
Coronary artery disease, Atherothrombosis, Thrombin generation, Platelet Acetyl Coenzyme A carboxylase phosphorylation
Medical subject headings
Coronary Artery Disease, Acute Coronary Syndrome, Coronary Thrombosis, Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Platelet Acetyl Coenzyme A Carboxylase analysis in CADDiagnostic test

Study groups in NCT03034148
Study groupRoleWhat they receive
Coronary artery diseaseOtherblood sampling for biomarkers assessment in a population undergoing coronary angiogram
Receives: Diagnostic Test: Platelet Acetyl Coenzyme A Carboxylase analysis in CAD

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. an increase in platelet ACC phosphorylation state in patients with coronary artery disease

    Measured: 2 years

Secondary outcomes (3)
  1. a correlation between thrombin generation markers and platelet P-ACC in overall population.

    Measured: 2 years

  2. platelet ACC phosphorylation state according clinical severity of CAD (stable versus unstable patients)

    Measured: 2 years

  3. the role of platelet P-ACC in predicting the risk of the patient for future cardiovascular events (death, myocardial infarction, stroke)

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2017 (estimated)
  2. Study startMar 2015
  3. Primary completionFeb 2016
  4. Study completionFeb 2016

Resources

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
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
188 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03034148
Sponsor's protocol ID
cb07012015
Acronym
ACCTHEROMA
Status last verified
Feb 2017
First submitted
25 Jan 2017
Last updated
17 Feb 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Onselaer MB, Oury C, Hunter RW, Eeckhoudt S, Barile N, Lecut C, Morel N, Viollet B, Jacquet LM, Bertrand L, Sakamoto K, Vanoverschelde JL, Beauloye C, Horman S. The Ca(2+) /calmodulin-dependent kinase kinase beta-AMP-activated protein kinase-alpha1 pathway regulates phosphorylation of cytoskeletal targets in thrombin-stimulated human platelets. J Thromb Haemost. 2014 Jun;12(6):973-86. doi: 10.1111/jth.12568.

    PubMed 24655923
  • Robaux V, Kautbally S, Ginion A, Dechamps M, Lejeune S, Menghoum N, Bertrand L, Pouleur AC, Horman S, Beauloye C. Dual antiplatelet therapy is associated with high alpha-tubulin acetylation in circulating platelets from coronary artery disease patients. Platelets. 2023 Dec;34(1):2250002. doi: 10.1080/09537104.2023.2250002.

    PubMed 37700239

Questions about this trial

What is this clinical trial studying?

A study testing Platelet Acetyl Coenzyme A Carboxylase analysis in CAD in people with Coronary Artery Disease and Acute Coronary Syndrome, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.

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 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: finished, as of the sponsor's last update on 17 Feb 2017. 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 Belgium. 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?

an increase in platelet ACC phosphorylation state in patients with coronary artery disease (time frame: 2 years). 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 NCT03034148, 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 17 Feb 2017; AzTrials last refreshed its copy on 8 Nov 2026.

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