Contribution of the Pharmacological Profile of the A2A Re... | NCT04640844

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

NCT04640844

Sponsor

Assistance Publique Hopitaux De Marseille

Status

Unknown status

Last Update Posted

May 28, 2021Actual

Enrollment

170Estimated

Phase

Not Applicable

Conditions

Chronic Coronary Artery Disease

Interventions

blood sample

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2020-A00686-33	Other Identifier	idrcb

Status Module

Record Verification Date

May 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 25, 2021Actual

Primary Completion Date

Dec 2022Estimated

Completion Date

Jun 2023Estimated

First Submitted Date

Nov 12, 2020

First Submission Date that Met QC Criteria

Nov 18, 2020

First Posted Date

Nov 23, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 27, 2021

Last Update Posted Date

May 28, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

170Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
patients hospitalized	Experimental	for surgery of the aorta and / or arteries of the lower limbs.	Biological: blood sample

Interventions

Name	Type	Description	Arm Group Labels	Other Names
blood sample	Biological	measuring the expression and function of lymphocyte A2A receptors.	patients hospitalized

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Dosage of adenosine	measuring the expression and function of lymphocyte A2A receptors.	24 MONTHS

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
ALAEXANDRA GIULIANI	Contact	0491382747		alexandra.giuliani@ap-hm.fr

Overall Officials

Name	Affiliation	Role
Emilie GARRIDO PRADALIE	Assistance Publique Hopitaux De Marseille	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assistance Publique Hopitaux de Marseille	Recruiting	Marseille			France

Intervention Browse Module

MeSH Terms

ID	Term
D001800	Blood Specimen Collection

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

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Browse Branches

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