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Coronary Artery DiseasePHYCONCT06008041

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

An observational study of Coronary Artery Disease and Coronary Microvascular Dysfunction, run by University Hospital, Brest at 1 site in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 to 100 years
How many people
400 participants
Where
1 siteFrance
Study dates
13 Jul 2023to 1 Apr 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: * Diabetes mellitus * High blood pressure * Aortic stenosis * Hypertrophic cardiopathy * Dilated cardiopathy * Stress cardiopathy * Elderly people > 75 years old * Acute coronary syndrome * Preserved heart failure * Cardiac amyloidosis

Who may be able to join

  • Intermediate coronary lesion (between 50 and 70%)

Who cannot join

  • Hemodynamic instability
  • Adenosine hypersensitivity
  • Asthma
  • Severe chronic obstructive pulmonary disease
  • Long QTc
  • Wolff parkinson white
Show all 10Show fewer
  • High degree atriovenricular block
  • Left-right shunt
  • Carotid artery stenosis with hemodynamic insufficiency
  • Pregnancy

Trial locations and contacts

1 site in 1 country.

France1 site

  • Chu Brest

    Brest, 29609

Other trials in France

About this study

Official title: Multimodal Epicardial and Endocardial COronary PHYsiological Evaluation in Pathological Situations

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.

Keywords
Coronary Artery Disease, Coronary Physiology, Index of Microcirculatory Resistance (IMR)
Medical subject headings
Coronary Artery Disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Index of Microcirculatory Resistance (IMR)

    IMR = Pd x Tmn at maximal hyperhemia Normal range < 25

    Measured: During coronary angiography

Secondary outcomes (7)

  1. Fractional Flow Reserve (FFR)

    FFR = Pd/Pa at maximal hyperhemia Normal value > 0.80

    Measured: During coronary angiography

  2. Coronary Flow Reserve (CFR)

    CFR = Hyperhemic flow / Resting flow Normal value > 2

    Measured: During coronary angiography

  3. Resting Full cycle Ratio (RFR)

    Lowest Pd/Pa value in systole and diastole (mean of 5 consecutive cardiac cycles) Normal value > 0.80

    Measured: During coronary angiography

  4. Quantitative Flow Ratio (QFR)

    Normal value > 0.80

    Measured: During coronary angiography

  5. Angio-IMR

    Estimated hyperemic Pa × angio-FFR × [vessel length/(K × Vdiastole)] Normal value < 25

    Measured: During coronary angiography

  6. Death

    Measured: 12 months

  7. Angina pectoris (CCS)

    Grade I : Angina with strenuous or rapid or prolonged exertion at work or recreation Grade II : Slight limitation of ordinary activity Grade III : Marked limitation of ordinary physical activity Grade IV : Inability to carry on any physical activity without discomfort, anginal syndrome may be present at rest

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Aug 2023
  2. Study start13 Jul 2023
  3. Primary completion13 Jul 2023
  4. Study completion1 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06008041
Sponsor's protocol ID
29BRC23.0037 - PHYCO
Acronym
PHYCO
Status last verified
Aug 2023
First submitted
16 Aug 2023
Last updated
28 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All collected data that underlie results in a publication

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease and Coronary Microvascular Dysfunction, run by University Hospital, Brest at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 28 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Index of Microcirculatory Resistance (IMR) (time frame: During coronary angiography). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06008041.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2023.

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