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

Chronic Coronary Artery Disease Clinical Trial

— RIMACI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04640844
• Other study ID #: 2020-13
• Secondary ID: 2020-A00686-33
• Status: Recruiting
• Phase: N/A
• Start date: January 25, 2021
• Est. completion date: June 2023

Study information

• Verified date: May 2021
• Source: Assistance Publique Hopitaux De Marseille
• Contact: ALAEXANDRA GIULIANI
• Phone: 0491382747
• Email: alexandra.giuliani[@]ap-hm.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: June 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Coronary Artery Disease
• Coronary Artery Disease
• Ischemia
• Myocardial Ischemia

Intervention

Biological:
• blood sample
measuring the expression and function of lymphocyte A2A receptors.

Locations

Country	Name	City	State
France	Assistance Publique Hopitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dosage of adenosine	measuring the expression and function of lymphocyte A2A receptors.	24 MONTHS