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Platelet Acetyl Coenzyme A Carboxylase Phosphorylation in Coronary Artery Disease (ACCTHEROMA)

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ClinicalTrials.gov Identifier: NCT03034148
Recruitment Status : Completed
First Posted : January 27, 2017
Last Update Posted : February 17, 2017
Sponsor:
Information provided by (Responsible Party):
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Coronary Artery Disease Acute Coronary Syndrome Coronary Thrombosis Diagnostic Test: Platelet Acetyl Coenzyme A Carboxylase analysis in CAD Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 188 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Prospective Evaluation of Acetyl-Coenzyme A Carboxylase Phosphorylation State in Platelets in Atherothrombotic Coronary Artery Disease.
Study Start Date : March 2015
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Coronary artery disease
blood sampling for biomarkers assessment in a population undergoing coronary angiogram
Diagnostic Test: Platelet Acetyl Coenzyme A Carboxylase analysis in CAD



Primary Outcome Measures :
  1. an increase in platelet ACC phosphorylation state in patients with coronary artery disease [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. a correlation between thrombin generation markers and platelet P-ACC in overall population. [ Time Frame: 2 years ]
  2. platelet ACC phosphorylation state according clinical severity of CAD (stable versus unstable patients) [ Time Frame: 2 years ]
  3. the role of platelet P-ACC in predicting the risk of the patient for future cardiovascular events (death, myocardial infarction, stroke) [ Time Frame: 3 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  • Abnormal platelet count
  • Heart transplanted patients
  • Active hepatitis B or C or HIV patients
  • Any contra-indication for coronary angiography.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03034148


Locations
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Belgium
Cliniques Universitaires Saint Luc
Brussels, Belgium, 1200
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Investigators
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Principal Investigator: Christophe Beauloye, MD, PhD Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Publications of Results:
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Responsible Party: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT03034148     History of Changes
Other Study ID Numbers: cb07012015
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: February 17, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:
Coronary artery disease
Atherothrombosis
Thrombin generation
Platelet Acetyl Coenzyme A carboxylase phosphorylation
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Thrombosis
Acute Coronary Syndrome
Coronary Thrombosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Embolism and Thrombosis