Post-Revascularization Optimization and PHysiological Evaluation of intermediaTe Lesions

Launched by CATHOLIC UNIVERSITY OF THE SACRED HEART · Sep 23, 2021

Keywords

ClinConnect Summary

The PROPHET-FFR trial is studying how carefully checking heart function after a procedure to open narrowed arteries can affect a patient’s health in the long run. This trial is focused on patients with conditions like stable angina, heart attacks, or other forms of coronary disease who need a specific heart test called coronary angiography to see how well their heart arteries are working. To participate, patients should have at least one artery that is narrowed but not completely blocked (between 40% and 80%), and they must be able to understand and agree to take part in the study.

If you qualify and decide to join, you will undergo standard heart testing and monitoring after your procedure to help doctors better understand how your heart is functioning. The trial is currently looking for participants aged 65 to 74, regardless of gender. It's important to note that people with certain serious health issues, like severe lung disease or advanced kidney disease, may not be eligible to participate. This study aims to improve how heart care is provided in the future by learning from the experiences of participants.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • requiring coronary angiography to assess coronary artery disease;
• • having at least one angiographically intermediate coronary stenosis (eg. 40%-80%) on any vessel requiring invasive functional assessment using FFR (and/or any other surrogate index)
• • being able and legally entitled to give informed consent
• Exclusion Criteria:
• • history of severe poorly uncontrolled pulmonary disease
• • hemodynamic instability during the diagnostic or therapeutic procedures;
• • known adenosine intolerance
• • need of mechanical circulatory or ventilatory support;
• • stage IV chronic kidney disease.
• • life expectancy \<1 year
• • patients gaining indication to surgical revascularization;
• • major procedural complications during percutaneous revascularization (cardiac arrest needing cardiopulmonary resuscitation, major bleeding , large iatrogenic coronary dissection, coronary embolization in a main vessel, suspected stroke) making post-PCI functional evaluation unsafe or impossible.