Ischemic Heart DiseasePROPHET-FFRNCT05056662
Post-Revascularization Optimization and PHysiological Evaluation of intermediaTe Lesions
An observational study of Ischemic Heart Disease and Angina, Stable, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial summary
PROPHET-FFR is a single center ambispective registry aiming to explore the impact of post-revascularization functional assessment on later outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Heart Disease, Angina, Stable, Non ST Elevation Myocardial Infarction
- What is being tested?
- Invasive functional evaluation with either Pd/Pa, FFR, iFR or contrast FFR
- How many people
- 1,000 participants
- Where
- 1 siteItaly
- Study dates
- 4 Jun 2020to 1 Oct 2025
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients requiring invasive functional evaluation of epicardial stenosis to guide revascularization.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Policlinico Universitario Agostino Gemelli
Rome, RM
ANTONIO MARIA LEONE, PI, antoniomarialeone@gmail.com
About this study
Official title: Post-Revascularization Optimization and PHysiological Evaluation of intermediaTe Lesions: an FFR-based Single Center Registry
PROPHET-FFR is a single center ambispective registry aiming to explore the impact of post-revascularization functional assessment on later outcomes.
Read the 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.
- Conditions
- Ischemic Heart Disease, Angina, Stable, Non ST Elevation Myocardial Infarction, ST Elevation Myocardial Infarction, Unstable Angina, Coronary Disease
- Being tested
- Invasive functional evaluation with either Pd/Pa, FFR, iFR or contrast FFR
- Medical subject headings
- Myocardial Ischemia, Angina, Stable, Non-ST Elevated Myocardial Infarction, ST Elevation Myocardial Infarction, Angina, Unstable, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Invasive functional evaluation with either Pd/Pa, FFR, iFR or contrast FFRDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients with negative invasive functional evaluation Receives: Diagnostic Test: Invasive functional evaluation with either Pd/Pa, FFR, iFR or contrast FFR | |
| Group 2 | Patients with positive invasive functional evaluation undergoing PCI Receives: Diagnostic Test: Invasive functional evaluation with either Pd/Pa, FFR, iFR or contrast FFR | |
| Group 3 | Patients with positive invasive functional evaluation undergoing PCI and subsequent retest of functional indexes Receives: Diagnostic Test: Invasive functional evaluation with either Pd/Pa, FFR, iFR or contrast FFR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of composite of Major Adverse Cardiovascular Events (MACE) [ Cardiac Death/Myocardial Infarction/Target Vessel Failure (TVF)]
Measured: 2 years
Secondary outcomes (12)
Rate of any component of MACE (Cardiac Death/Myocardial Infarction/Target Vessel Failure (TVF)]
Measured: 1 year, 3 years, 5 years
Rate of all-cause Death
Measured: 1 year, 3 years, 5 years
Rate of recurrent or persistent angina
Measured: 1 year, 3 years, 5 years
Percentage of change in angina intensity assessed by shortened Seattle Angina Questionnaire-7
A score ranging from 0 to 100, with the higher values associated with less severe symptoms
Measured: 1 year, 3 years, 5 years
Rate of cardiac hospitalizations
Any hospitalization for cardiac causes
Measured: 1 year, 3 years, 5 years
absolute and relative change in functional indexes measured before and after any step of the study procedure
Measured: intraprocedural
post-procedural troponin level
ng/L
Measured: 24 hours and 48 hours
post-procedural creatinine level
mg/dL
Measured: 24 hours and 48 hours
procedural cost
Euro
Measured: intraprocedural
fluoroscopy time
minutes
Measured: intraprocedural
contrast dose
mL
Measured: intraprocedural
number of stents implanted and balloon used for optimization
Measured: intraprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2021
- Study start4 Jun 2020
- Primary completion4 Jun 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 1,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Responsible party
- Principal investigator, Antonio Maria Leone, MD, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05056662
- Sponsor's protocol ID
- 3237
- Acronym
- PROPHET-FFR
- Status last verified
- Aug 2023
- First submitted
- 22 Jul 2021
- Last updated
- 30 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Galante D, Migliaro S, Di Giusto F, Anastasia G, Petrolati E, Vicere A, Zimbardo G, Cialdella P, Romagnoli E, Aurigemma C, Burzotta F, Trani C, Martin-Reyes R, Baptista SB, Faria D, Amabile N, Raposo L, Crea F, Leone AM. Age and Vasodilator Response to Different Hyperemic Agents: Adenosine versus Contrast Medium. Rev Cardiovasc Med. 2024 Jul 2;25(7):239. doi: 10.31083/j.rcm2507239. eCollection 2024 Jul.
PubMed 39139436
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Revascularization Optimization and PHysiological Evaluation of intermediaTe Lesions: an FFR-based Single Center Registry
- ClinicalTrials.gov ID
- NCT05056662
- Acronym / sponsor ID
- PROPHET-FFR / 3237
- Conditions
- Ischemic Heart Disease, Angina, Stable, Non ST Elevation Myocardial Infarction, ST Elevation Myocardial Infarction, Unstable Angina, Coronary Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Collaborators
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study start
- 4 Jun 2020 (actual)
- Primary completion
- 4 Jun 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 24 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
PROPHET-FFR is a single center ambispective registry aiming to explore the impact of post-revascularization functional assessment on later outcomes.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Diagnostic Test: Invasive functional evaluation with either Pd/Pa, FFR, iFR or contrast FFRPatients with negative invasive functional evaluation |
| Group 2 | – | Diagnostic Test: Invasive functional evaluation with either Pd/Pa, FFR, iFR or contrast FFRPatients with positive invasive functional evaluation undergoing PCI |
| Group 3 | – | Diagnostic Test: Invasive functional evaluation with either Pd/Pa, FFR, iFR or contrast FFRPatients with positive invasive functional evaluation undergoing PCI and subsequent retest of functional indexes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients requiring invasive functional evaluation of epicardial stenosis to guide revascularization.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Invasive functional evaluation with either Pd/Pa, FFR, iFR or contrast FFREnrolled 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. | Diagnostic test | Group 1, Group 2, Group 3 |
Primary outcome
Rate of composite of Major Adverse Cardiovascular Events (MACE) [ Cardiac Death/Myocardial Infarction/Target Vessel Failure (TVF)]
Time frame: 2 years
12 secondary outcomes
Rate of any component of MACE (Cardiac Death/Myocardial Infarction/Target Vessel Failure (TVF)]
Time frame: 1 year, 3 years, 5 years
Rate of all-cause Death
Time frame: 1 year, 3 years, 5 years
Rate of recurrent or persistent angina
Time frame: 1 year, 3 years, 5 years
Percentage of change in angina intensity assessed by shortened Seattle Angina Questionnaire-7
Time frame: 1 year, 3 years, 5 years
Rate of cardiac hospitalizations
Time frame: 1 year, 3 years, 5 years
absolute and relative change in functional indexes measured before and after any step of the study procedure
Time frame: intraprocedural
post-procedural troponin level
Time frame: 24 hours and 48 hours
post-procedural creatinine level
Time frame: 24 hours and 48 hours
procedural cost
Time frame: intraprocedural
fluoroscopy time
Time frame: intraprocedural
contrast dose
Time frame: intraprocedural
number of stents implanted and balloon used for optimization
Time frame: intraprocedural
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
- Derived from this study: PubMed 39139436Galante D, Migliaro S, Di Giusto F, Anastasia G, Petrolati E, Vicere A, Zimbardo G, Cialdella P, Romagnoli E, Aurigemma C, Burzotta F, Trani C, Martin-Reyes R, Baptista SB, Faria D, Amabile N, Raposo L, Crea F, Leone AM. Age and Vasodilator Response to Different Hyperemic Agents: Adenosine versus Contrast Medium. Rev Cardiovasc Med. 2024 Jul 2;25(7):239. doi: 10.31083/j.rcm2507239. eCollection 2024 Jul.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Heart Disease and Angina, Stable, run by Catholic University of the Sacred Heart at 1 site in Italy.
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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 30 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antonio Maria Leone, PI (0630155950, antoniomarialeone@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of composite of Major Adverse Cardiovascular Events (MACE) [ Cardiac Death/Myocardial Infarction/Target Vessel Failure (TVF)] (time frame: 2 years). 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 NCT05056662, which also lists 1 linked publication.
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 30 Aug 2023.