Multimodal Epicardial and Endocardial COronary PHYsiological Evaluation in Pathological Situations (PHYCO)

NCT ID: NCT06008041

Last Updated: 2023-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-13

Study Completion Date

2027-04-01

Brief Summary

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When performing coronary angiography in a stable situation, the identification of an intermediate coronary lesion (between 50 and 70%) is common, and requires additional functional evaluation. The gold standard for this evaluation is Fractional Flow Reserve (FFR). FFR is a flow ratio transformed into a pressure ratio by simplification, neglecting some parameters, especially microcirculatory resistance.

The aim of this study is to investigate hemodynamic and structural assessment induced in specific conditions, and their repercussion on functional assessment by FFR to implement the diagnostic approach and personalize it for each patient.

Detailed Description

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Conditions

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Coronary Artery Disease Coronary Microvascular Dysfunction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Intermediate coronary lesion (between 50 and 70%)

Exclusion Criteria

* Hemodynamic instability
* Adenosine hypersensitivity
* Asthma
* Severe chronic obstructive pulmonary disease
* Long QTc
* Wolff parkinson white
* High degree atriovenricular block
* Left-right shunt
* Carotid artery stenosis with hemodynamic insufficiency
* Pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Brest

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chu Brest

Brest, , France

Site Status

Countries

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France

Other Identifiers

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29BRC23.0037 - PHYCO

Identifier Type: -

Identifier Source: org_study_id

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