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NCT Number: NCT06008041

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Coronary Microvascular Dysfunction Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Brest

Brest, 29609, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Index of Microcirculatory Resistance (IMR)

    Time frame: During coronary angiography

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

Secondary outcomes

  1. Fractional Flow Reserve (FFR)

    Time frame: During coronary angiography

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

  2. Coronary Flow Reserve (CFR)

    Time frame: During coronary angiography

    CFR = Hyperhemic flow / Resting flow Normal value > 2

  3. Resting Full cycle Ratio (RFR)

    Time frame: During coronary angiography

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

  4. Quantitative Flow Ratio (QFR)

    Time frame: During coronary angiography

    Normal value > 0.80

  5. Angio-IMR

    Time frame: During coronary angiography

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

  6. Death

    Time frame: 12 months

  7. Angina pectoris (CCS)

    Time frame: 12 months

    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

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study title

Multimodal Epicardial and Endocardial COronary PHYsiological Evaluation in Pathological Situations

Acronym: PHYCO

Important dates

Study start
2023
Primary completion
2023
Study completion
2027
First posted
Aug 23, 2023
Registry last updated
Aug 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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