NCT04640844

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
170

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 23, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

January 25, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

May 28, 2021

Status Verified

May 1, 2021

Enrollment Period

1.8 years

First QC Date

November 12, 2020

Last Update Submit

May 27, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Dosage of adenosine

    measuring the expression and function of lymphocyte A2A receptors.

    24 MONTHS

Study Arms (1)

patients hospitalized

EXPERIMENTAL

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

Biological: blood sample

Interventions

blood sampleBIOLOGICAL

measuring the expression and function of lymphocyte A2A receptors.

patients hospitalized

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, France

RECRUITING

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Emilie GARRIDO PRADALIE

    Assistance Publique Hopitaux De Marseille

    STUDY DIRECTOR

Central Study Contacts

ALAEXANDRA GIULIANI

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2020

First Posted

November 23, 2020

Study Start

January 25, 2021

Primary Completion

December 1, 2022

Study Completion

June 1, 2023

Last Updated

May 28, 2021

Record last verified: 2021-05

Locations