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Contribution of the Pharmacological Profile of the A2A Receptor to Adenosine in the Diagnosis of Myocardial Ischemia (RIMACI)

Primary Purpose

Chronic Coronary Artery Disease

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood sample
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Coronary Artery Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients admitted for preoperative assessment of vascular surgery of the aorta and / or arteries of the lower limbs.
  • Adult person (age> 18).
  • Affiliated with a social security scheme.
  • Signature of informed consent.

Exclusion Criteria:

  • Patients with a history of coronary artery disease awaiting revascularization.
  • Hyperthyroidism, anemia (Hb <13 g / dL).
  • Contraindication to the practice of coronary angiography, stress echocardiography or myocardial scintigraphy.
  • Unstable hemodynamic state or cardiogenic shock.
  • Adults protected under guardianship, curatorship or legal protection.
  • Pregnant or lactating women

Sites / Locations

  • Assistance Publique Hopitaux de MarseilleRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

patients hospitalized

Arm Description

for surgery of the aorta and / or arteries of the lower limbs.

Outcomes

Primary Outcome Measures

Dosage of adenosine
measuring the expression and function of lymphocyte A2A receptors.

Secondary Outcome Measures

Full Information

First Posted
November 12, 2020
Last Updated
May 27, 2021
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT04640844
Brief Title
Contribution of the Pharmacological Profile of the A2A Receptor to Adenosine in the Diagnosis of Myocardial Ischemia
Acronym
RIMACI
Official Title
Contribution of the Pharmacological Profile of the A2A Receptor to Adenosine in the Diagnosis of Myocardial Ischemia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 25, 2021 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The chronic coronary artery disease could be detected by a drop in the expression of A2A receptors to adenosine, while high values of the KD / EC50 ratio are a sign of coronary ischemia. Knowing the number of A2A receptors in circulating lymphocytes could allow detection of coronary artery disease and evaluating the functionality of A2A receptors in circulating lymphocytes could allow quantification of myocardial ischemia. Thus, a simple and unique blood sample would quickly detect patients with life-threatening coronary ischemia. This would avoid prolonged hospitalizations and costly non-invasive tests (stress echocardiography, myocardial scintigraphy) in patients without coronary artery disease.
Detailed Description
The main objective of this study is to evaluate the discriminating capacities of A2A adenosine receptors expression on the surface of circulating lymphocytes for the detection of coronary artery disease in patients hospitalized for surgery of the aorta and / or arteries of the lower limbs. The secondary objectives are: Assessment of the discriminating capacities of the functionality (KD / EC50) of A2A adenosine receptors on the surface of circulating lymphocytes, for the diagnosis of myocardial ischemia in patients hospitalized for surgery of the aorta and / or arteries of legs. Determinate the best threshold for discriminating patients with coronary artery disease and estimate the discriminating performance associated with this threshold. Determinate the best threshold for discriminating patients with myocardial ischemia and estimate the discriminating performance associated with this threshold.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Coronary Artery Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
patients hospitalized
Arm Type
Experimental
Arm Description
for surgery of the aorta and / or arteries of the lower limbs.
Intervention Type
Biological
Intervention Name(s)
blood sample
Intervention Description
measuring the expression and function of lymphocyte A2A receptors.
Primary Outcome Measure Information:
Title
Dosage of adenosine
Description
measuring the expression and function of lymphocyte A2A receptors.
Time Frame
24 MONTHS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients admitted for preoperative assessment of vascular surgery of the aorta and / or arteries of the lower limbs. Adult person (age> 18). Affiliated with a social security scheme. Signature of informed consent. Exclusion Criteria: Patients with a history of coronary artery disease awaiting revascularization. Hyperthyroidism, anemia (Hb <13 g / dL). Contraindication to the practice of coronary angiography, stress echocardiography or myocardial scintigraphy. Unstable hemodynamic state or cardiogenic shock. Adults protected under guardianship, curatorship or legal protection. Pregnant or lactating women
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ALAEXANDRA GIULIANI
Phone
0491382747
Email
alexandra.giuliani@ap-hm.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emilie GARRIDO PRADALIE
Organizational Affiliation
Assistance Publique Hopitaux De Marseille
Official's Role
Study Director
Facility Information:
Facility Name
Assistance Publique Hopitaux de Marseille
City
Marseille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PIERRE DEHARO

12. IPD Sharing Statement

Learn more about this trial

Contribution of the Pharmacological Profile of the A2A Receptor to Adenosine in the Diagnosis of Myocardial Ischemia

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