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Post-Revascularization Optimization and PHysiological Evaluation of intermediaTe Lesions (PROPHET-FFR)

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ClinicalTrials.gov Identifier: NCT05056662
Recruitment Status : Recruiting
First Posted : September 24, 2021
Last Update Posted : September 24, 2021
Sponsor:
Collaborator:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Information provided by (Responsible Party):
Antonio Maria Leone, MD, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary:
PROPHET-FFR is a single center ambispective registry aiming to explore the impact of post-revascularization functional assessment on later outcomes.

Condition or disease Intervention/treatment
Ischemic Heart Disease Angina, Stable Non ST Elevation Myocardial Infarction ST Elevation Myocardial Infarction Unstable Angina Coronary Disease Diagnostic Test: Invasive functional evaluation with either Pd/Pa, FFR, iFR or contrast FFR

Detailed Description:

PROPHET-FFR is a ambispective observational study enrolling patients that need invasive functional evaluation in the diagnostic workup of coronary artery disease.

Clinical outcomes of patients that undergo functional assessment after PCI will be compared both to patients undergoing PCI without further evaluations and both to patients that will be deferred due to to negative functional evaluation.

Since the observational nature of the study the decision to perform post-PCI physiological assessment will be left to operator's discretion.

In case of post-PCI functional evaluation results that will be deemed as unsatisfactory by the operator further actions can be taken in order to optimize procedural result. The decision on this opportunity as well as the choice of the strategy to adopt are left to operator's discretion.

The primary endpoint of the study is the rate of MACE defined as the composite of spontaneous MI, target vessel failure, cardiac deaths at 24 months. Follow up will be performed by telephone contact and medical records screening at 12, 24 and 36 months.

Moreover data about in-hospital events will be collected including the release of myocardial damage markers, change in Creatinine, and lenght of hospital stay.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Post-Revascularization Optimization and PHysiological Evaluation of intermediaTe Lesions: an FFR-based Single Center Registry
Actual Study Start Date : June 4, 2020
Estimated Primary Completion Date : June 4, 2025
Estimated Study Completion Date : October 1, 2025

Group/Cohort Intervention/treatment
Group 1
Patients with negative invasive functional evaluation
Diagnostic Test: Invasive functional evaluation with either Pd/Pa, FFR, iFR or contrast FFR
Enrolled patients will undergo invasive functional evaluation of coronary stenosis followed by percutaneous revascularization if appropriate. Patients in Group 3 will have target lesion re-assessed using either PdPa, FFR, iFR or contrast FFR.

Group 2
Patients with positive invasive functional evaluation undergoing PCI
Diagnostic Test: Invasive functional evaluation with either Pd/Pa, FFR, iFR or contrast FFR
Enrolled patients will undergo invasive functional evaluation of coronary stenosis followed by percutaneous revascularization if appropriate. Patients in Group 3 will have target lesion re-assessed using either PdPa, FFR, iFR or contrast FFR.

Group 3
Patients with positive invasive functional evaluation undergoing PCI and subsequent retest of functional indexes
Diagnostic Test: Invasive functional evaluation with either Pd/Pa, FFR, iFR or contrast FFR
Enrolled patients will undergo invasive functional evaluation of coronary stenosis followed by percutaneous revascularization if appropriate. Patients in Group 3 will have target lesion re-assessed using either PdPa, FFR, iFR or contrast FFR.




Primary Outcome Measures :
  1. Rate of composite of Major Adverse Cardiovascular Events (MACE) [ Cardiac Death/Myocardial Infarction/Target Vessel Failure (TVF)] [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Rate of any component of MACE (Cardiac Death/Myocardial Infarction/Target Vessel Failure (TVF)] [ Time Frame: 1 year, 3 years, 5 years ]
  2. Rate of all-cause Death [ Time Frame: 1 year, 3 years, 5 years ]
  3. Rate of recurrent or persistent angina [ Time Frame: 1 year, 3 years, 5 years ]
  4. Percentage of change in angina intensity assessed by shortened Seattle Angina Questionnaire-7 [ Time Frame: 1 year, 3 years, 5 years ]
    A score ranging from 0 to 100, with the higher values associated with less severe symptoms

  5. Rate of cardiac hospitalizations [ Time Frame: 1 year, 3 years, 5 years ]
    Any hospitalization for cardiac causes

  6. absolute and relative change in functional indexes measured before and after any step of the study procedure [ Time Frame: intraprocedural ]
  7. post-procedural troponin level [ Time Frame: 24 hours and 48 hours ]
    ng/L

  8. post-procedural creatinine level [ Time Frame: 24 hours and 48 hours ]
    mg/dL

  9. procedural cost [ Time Frame: intraprocedural ]
    Euro

  10. fluoroscopy time [ Time Frame: intraprocedural ]
    minutes

  11. contrast dose [ Time Frame: intraprocedural ]
    mL

  12. number of stents implanted and balloon used for optimization [ Time Frame: intraprocedural ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients requiring invasive functional evaluation of epicardial stenosis to guide revascularization.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05056662


Contacts
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Contact: Antonio Maria Leone, PI 0630155950 antoniomarialeone@gmail.com

Locations
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Italy
Policlinico Universitario Agostino Gemelli Recruiting
Rome, RM, Italy
Contact: ANTONIO MARIA LEONE, PI       antoniomarialeone@gmail.com   
Sponsors and Collaborators
Catholic University of the Sacred Heart
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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Responsible Party: Antonio Maria Leone, MD, Principal Investigator, Head of Chronic Coronary Syndromes Department at Fondazione Policlinico A. Gemelli, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
ClinicalTrials.gov Identifier: NCT05056662    
Other Study ID Numbers: 3237
First Posted: September 24, 2021    Key Record Dates
Last Update Posted: September 24, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myocardial Infarction
Heart Diseases
Angina Pectoris
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
ST Elevation Myocardial Infarction
Angina, Unstable
Non-ST Elevated Myocardial Infarction
Angina, Stable
Infarction
Ischemia
Pathologic Processes
Necrosis
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations
Arteriosclerosis
Arterial Occlusive Diseases