Fractional Flow Reserve, MyocardialPREDICTNCT03237169
Performance of a New REsting Pressure Index During Invasive Angiography Compared To Adenosine Hyperemic FFR
An observational study of Fractional Flow Reserve, Myocardial and Coronary Artery Disease, run by Centro Hospitalar Lisboa Ocidental at 6 sites in 4 countries.
Trial summary
To test the feasibility and diagnostic accuracy of a new automated pressure derived resting index (Pd/Pamin), using FFR as gold standard, in de novo coronary lesions in which invasive physiological evaluation is warranted. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fractional Flow Reserve, Myocardial, Coronary Artery Disease
- How many people
- 100 participants
- Where
- 6 sitesin 4 countries
- Study dates
- 28 Oct 2016to Sep 2018
- 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: Consecutive subjects scheduled for coronary angiography or PCI in whom operator decides to perform FFR will be approached for enrollment. Being a first-in-man study of a novel pressure index intended for future validation and use in a clinical setting, a full assessment of its range throughout the entire spectrum of lesion severity is warranted. As such, the protocol will allow for the inclusion of both less severe as well as of critical (>90%) lesions. Patients with either single or multiple vessel disease will be included. Data on additional lesions may or may not be collected but will not be used in the study. Vessels with sequential stenosis and tandem lesions will be evaluated and treated according to routine clinical practice, but not included in the study data collected.
Who may be able to join
- Patients undergoing FFR assessment for standard clinical indications, according to individual operator decision.
- Age ≥ 18 years.
- Provided signed written informed consent for data collection the collection.
- De novo coronary artery disease in target vessel.
- Single or multiple vessel disease.
- Patient eligible for elective or ad hoc PCI (or CABG), if revascularization is deemed indicated, in the setting of stable coronary artery disease or non-culprit lesions of non-ST elevation acute coronary syndromes (only in deferred procedures).
- Stenosis deemed amenable for both evaluation with a pressure wire and for potential revascularization.
Who cannot join
- Subjects with restenosis in the target vessel.
- Known severe renal insufficiency (examples being but not limited to eGFR <30 ml/kg/min, serum creatinine ≥ 2.5 mg/dL or on dialysis).
- Aorto-ostial lesion location within 3 mm of the aorta junction (both right and left).
- Vessel(s) and lesion(s) not amenable for evaluation with a PressureWire™ and/or revascularization.
- Tandem lesions
- Moderate lesions in patients with multivessel disease in whom at least one lesion in another major epicardic vessel is severe (to minimize lesion interaction), unless the severe lesion is treated first (see above).
Show all 19Show fewer
- Left ventricular ejection fraction <50%
- Known severe left ventricular hypertrophy
- Atrial fibrillation or any other significant arrhythmia (including an heart rate <50/min on sinus rhythm)
- Systolic blood pressure <90 mmHg.
- Any other medical condition that in the opinion of the investigator will interfere with patient safety or study results
- Currently participating in another clinical study that interferes with study results.
- Pregnant or nursing females
- Planned or prior heart transplantation or listed for heart transplant.
- Any condition that precludes the subject from undergoing PCI or any of the protocol mandated procedures, for example subjects with a prior history heparin induced thrombocytopenia, known intolerance to adenosine or with a contra-indication for dual anti-platelet therapy.
- Patients with severe valvular disease
- Patients with severe pulmonary disease
- Culprit lesions in ACS patients are not to be included nor non-culprit lesions in patients with a recent STEMI undergoing staged procedures.
- Patients with a CTO, regardless of the presence and the extent of angiographic collaterals from the target vessel.
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
Portugal3 sites, 3 recruiting
- Recruiting
Hospital Prof. Doutor Fernando da Fonseca
Amadora, 2720-276
Sergio B Batista, MD
- Recruiting
Centro Hospitalar de Lisboa Ocidental - Hospital de Santa Cruz
Carnaxide, 2790-134
Luis Raposo, MD
- Recruiting
Centro Hospitalar de Lisboa Central (CHLC) - Hospital de Santa Marta
Lisbon
Ruben Ramos, MD
United States1 site, 1 recruiting
- Recruiting
St. Francis Hospital The Heart Center
New York, New York, 11576
Allen Jeremias, MD, 516-390-9640
France1 site, 1 recruiting
- Recruiting
Department of Cardiology, University Hospital
Lille
Eric VanBelle, MD
Italy1 site, 1 recruiting
- Recruiting
Institute of Cardiology, Catholic University of the Sacred Heart
Rome
Antonio M Leone, MD
About this study
To test the feasibility and diagnostic accuracy of a new automated pressure derived resting index (Pd/Pamin), using FFR as gold standard, in de novo coronary lesions in which invasive physiological evaluation is warranted.
Read the detailed description
Coronary lesions with a potential indication for percutaneous coronary intervention or warranting invasive physiological interrogation (in the opinion of the investigator) will undergo PressureWire™ assessment under 2 conditions: rest and adenosine hyperemia. The measurements at rest (standard Pd/Pa and Pd/Pamin) will be repeated to assess test/retest repeatability. Subsequent treatment decisions will be made by the operator according to the standard practice based on the adenosine FFR value together with all other clinical information.
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Prospective cohort | Prospective cohort of patients with stable or stabilized coronary artery disease and de novo coronary lesions, in whom functional evaluation is performed, according do standard clinical indications. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of Pd/Pamin vs FFR
Agreement will be tested using the established FFR 0.8 threshold as the binary reference standard.
Measured: baseline
Secondary outcomes (2)
Discriminative power of Pd/Pamin and the best cut-off, taking FFR as gold
ROC analysis using FFR as reference
Measured: baseline
Feasibility of Pd/Pamin measurements
Description of how often can Pd/Pamin can be measured accurately
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2017
- Study start28 Oct 2016
- Primary completionSep 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Fractional Flow Reserve, MyocardialStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Hospitalar Lisboa Ocidental
- Sponsor type
- Other government
- Collaborators
- Abbott Medical Devices, Cardiovascular Research Foundation, New York
- Responsible party
- Principal investigator, Luis Raposo, Centro Hospitalar Lisboa Ocidental
- Investigators
- Luis Raposo, MD, Principal investigator, Centro Hospitalar de Lisboa OcidentalSergio Bravo Baptista, MD, PhD, Study chair, Hospital Fernando da Fonseca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03237169
- Sponsor's protocol ID
- 2017-02
- Acronym
- PREDICT
- Status last verified
- May 2018
- First submitted
- 31 Jul 2017
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Levine GN, Bates ER, Blankenship JC, Bailey SR, Bittl JA, Cercek B, Chambers CE, Ellis SG, Guyton RA, Hollenberg SM, Khot UN, Lange RA, Mauri L, Mehran R, Moussa ID, Mukherjee D, Nallamothu BK, Ting HH; American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines; Society for Cardiovascular Angiography and Interventions. 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention. A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions. J Am Coll Cardiol. 2011 Dec 6;58(24):e44-122. doi: 10.1016/j.jacc.2011.08.007. Epub 2011 Nov 7. No abstract available.
PubMed 22070834Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS); European Association for Percutaneous Cardiovascular Interventions (EAPCI); Wijns W, Kolh P, Danchin N, Di Mario C, Falk V, Folliguet T, Garg S, Huber K, James S, Knuuti J, Lopez-Sendon J, Marco J, Menicanti L, Ostojic M, Piepoli MF, Pirlet C, Pomar JL, Reifart N, Ribichini FL, Schalij MJ, Sergeant P, Serruys PW, Silber S, Sousa Uva M, Taggart D. Guidelines on myocardial revascularization. Eur Heart J. 2010 Oct;31(20):2501-55. doi: 10.1093/eurheartj/ehq277. Epub 2010 Aug 29. No abstract available.
PubMed 20802248Mamas MA, Horner S, Welch E, Ashworth A, Millington S, Fraser D, Fath-Ordoubadi F, Neyses L, El-Omar M. Resting Pd/Pa measured with intracoronary pressure wire strongly predicts fractional flow reserve. J Invasive Cardiol. 2010 Jun;22(6):260-5.
PubMed 20516504Sen S, Escaned J, Malik IS, Mikhail GW, Foale RA, Mila R, Tarkin J, Petraco R, Broyd C, Jabbour R, Sethi A, Baker CS, Bellamy M, Al-Bustami M, Hackett D, Khan M, Lefroy D, Parker KH, Hughes AD, Francis DP, Di Mario C, Mayet J, Davies JE. Development and validation of a new adenosine-independent index of stenosis severity from coronary wave-intensity analysis: results of the ADVISE (ADenosine Vasodilator Independent Stenosis Evaluation) study. J Am Coll Cardiol. 2012 Apr 10;59(15):1392-402. doi: 10.1016/j.jacc.2011.11.003. Epub 2011 Dec 7.
PubMed 22154731Ganz P, Abben R, Friedman PL, Garnic JD, Barry WH, Levin DC. Usefulness of transstenotic coronary pressure gradient measurements during diagnostic catheterization. Am J Cardiol. 1985 Apr 1;55(8):910-4. doi: 10.1016/0002-9149(85)90716-7.
PubMed 3157307Gruntzig AR, Senning A, Siegenthaler WE. Nonoperative dilatation of coronary-artery stenosis: percutaneous transluminal coronary angioplasty. N Engl J Med. 1979 Jul 12;301(2):61-8. doi: 10.1056/NEJM197907123010201.
PubMed 449946Berry C, van 't Veer M, Witt N, Kala P, Bocek O, Pyxaras SA, McClure JD, Fearon WF, Barbato E, Tonino PA, De Bruyne B, Pijls NH, Oldroyd KG. VERIFY (VERification of Instantaneous Wave-Free Ratio and Fractional Flow Reserve for the Assessment of Coronary Artery Stenosis Severity in EverydaY Practice): a multicenter study in consecutive patients. J Am Coll Cardiol. 2013 Apr 2;61(13):1421-7. doi: 10.1016/j.jacc.2012.09.065. Epub 2013 Feb 6.
PubMed 23395076Ganz P, Harrington DP, Gaspar J, Barry WH. Phasic pressure gradients across coronary and renal artery stenoses in humans. Am Heart J. 1983 Dec;106(6):1399-406. doi: 10.1016/0002-8703(83)90052-2.
PubMed 6650363
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of a New REsting Pressure Index During Invasive Angiography Compared To Adenosine Hyperemic FFR
- ClinicalTrials.gov ID
- NCT03237169
- Acronym / sponsor ID
- PREDICT / 2017-02
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centro Hospitalar Lisboa OcidentalOther government
- Collaborators
- Abbott Medical Devices, Cardiovascular Research Foundation, New York
- Study start
- 28 Oct 2016 (actual)
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 2 Aug 2017 (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.
To test the feasibility and diagnostic accuracy of a new automated pressure derived resting index (Pd/Pamin), using FFR as gold standard, in de novo coronary lesions in which invasive physiological evaluation is warranted.
Detailed description
Coronary lesions with a potential indication for percutaneous coronary intervention or warranting invasive physiological interrogation (in the opinion of the investigator) will undergo PressureWire™ assessment under 2 conditions: rest and adenosine hyperemia. The measurements at rest (standard Pd/Pa and Pd/Pamin) will be repeated to assess test/retest repeatability. Subsequent treatment decisions will be made by the operator according to the standard practice based on the adenosine FFR value together with all other clinical information.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective cohort | – | –Prospective cohort of patients with stable or stabilized coronary artery disease and de novo coronary lesions, in whom functional evaluation is performed, according do standard clinical indications. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive subjects scheduled for coronary angiography or PCI in whom operator decides to perform FFR will be approached for enrollment. Being a first-in-man study of a novel pressure index intended for future validation and use in a clinical setting, a full assessment of its range throughout the entire spectrum of lesion severity is warranted. As such, the protocol will allow for the inclusion of both less severe as well as of critical (>90%) lesions. Patients with either single or multiple vessel disease will be included. Data on additional lesions may or may not be collected but will not be used in the study. Vessels with sequential stenosis and tandem lesions will be evaluated and treated according to routine clinical practice, but not included in the study data collected.
Key inclusion criteria (7 listed)
- Patients undergoing FFR assessment for standard clinical indications, according to individual operator decision.
- Age ≥ 18 years.
- Provided signed written informed consent for data collection the collection.
- De novo coronary artery disease in target vessel.
- Single or multiple vessel disease.
Key exclusion criteria (19 listed)
- Subjects with restenosis in the target vessel.
- Known severe renal insufficiency (examples being but not limited to eGFR <30 ml/kg/min, serum creatinine ≥ 2.5 mg/dL or on dialysis).
- Aorto-ostial lesion location within 3 mm of the aorta junction (both right and left).
- Vessel(s) and lesion(s) not amenable for evaluation with a PressureWire™ and/or revascularization.
- Tandem lesions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic accuracy of Pd/Pamin vs FFR
Time frame: baseline
Agreement will be tested using the established FFR 0.8 threshold as the binary reference standard.
2 secondary outcomes
Discriminative power of Pd/Pamin and the best cut-off, taking FFR as gold
Time frame: baseline
Feasibility of Pd/Pamin measurements
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
- Background: PubMed 22070834Levine GN, Bates ER, Blankenship JC, Bailey SR, Bittl JA, Cercek B, Chambers CE, Ellis SG, Guyton RA, Hollenberg SM, Khot UN, Lange RA, Mauri L, Mehran R, Moussa ID, Mukherjee D, Nallamothu BK, Ting HH; American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines; Society for Cardiovascular Angiography and Interventions. 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention. A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions. J Am Coll Cardiol. 2011 Dec 6;58(24):e44-122. doi: 10.1016/j.jacc.2011.08.007. Epub 2011 Nov 7. No abstract available.
- Background: PubMed 20802248Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS); European Association for Percutaneous Cardiovascular Interventions (EAPCI); Wijns W, Kolh P, Danchin N, Di Mario C, Falk V, Folliguet T, Garg S, Huber K, James S, Knuuti J, Lopez-Sendon J, Marco J, Menicanti L, Ostojic M, Piepoli MF, Pirlet C, Pomar JL, Reifart N, Ribichini FL, Schalij MJ, Sergeant P, Serruys PW, Silber S, Sousa Uva M, Taggart D. Guidelines on myocardial revascularization. Eur Heart J. 2010 Oct;31(20):2501-55. doi: 10.1093/eurheartj/ehq277. Epub 2010 Aug 29. No abstract available.
- Background: PubMed 20516504Mamas MA, Horner S, Welch E, Ashworth A, Millington S, Fraser D, Fath-Ordoubadi F, Neyses L, El-Omar M. Resting Pd/Pa measured with intracoronary pressure wire strongly predicts fractional flow reserve. J Invasive Cardiol. 2010 Jun;22(6):260-5.
- Background: PubMed 22154731Sen S, Escaned J, Malik IS, Mikhail GW, Foale RA, Mila R, Tarkin J, Petraco R, Broyd C, Jabbour R, Sethi A, Baker CS, Bellamy M, Al-Bustami M, Hackett D, Khan M, Lefroy D, Parker KH, Hughes AD, Francis DP, Di Mario C, Mayet J, Davies JE. Development and validation of a new adenosine-independent index of stenosis severity from coronary wave-intensity analysis: results of the ADVISE (ADenosine Vasodilator Independent Stenosis Evaluation) study. J Am Coll Cardiol. 2012 Apr 10;59(15):1392-402. doi: 10.1016/j.jacc.2011.11.003. Epub 2011 Dec 7.
- Background: PubMed 3157307Ganz P, Abben R, Friedman PL, Garnic JD, Barry WH, Levin DC. Usefulness of transstenotic coronary pressure gradient measurements during diagnostic catheterization. Am J Cardiol. 1985 Apr 1;55(8):910-4. doi: 10.1016/0002-9149(85)90716-7.
- Background: PubMed 449946Gruntzig AR, Senning A, Siegenthaler WE. Nonoperative dilatation of coronary-artery stenosis: percutaneous transluminal coronary angioplasty. N Engl J Med. 1979 Jul 12;301(2):61-8. doi: 10.1056/NEJM197907123010201.
- Background: PubMed 23395076Berry C, van 't Veer M, Witt N, Kala P, Bocek O, Pyxaras SA, McClure JD, Fearon WF, Barbato E, Tonino PA, De Bruyne B, Pijls NH, Oldroyd KG. VERIFY (VERification of Instantaneous Wave-Free Ratio and Fractional Flow Reserve for the Assessment of Coronary Artery Stenosis Severity in EverydaY Practice): a multicenter study in consecutive patients. J Am Coll Cardiol. 2013 Apr 2;61(13):1421-7. doi: 10.1016/j.jacc.2012.09.065. Epub 2013 Feb 6.
- Background: PubMed 6650363Ganz P, Harrington DP, Gaspar J, Barry WH. Phasic pressure gradients across coronary and renal artery stenoses in humans. Am Heart J. 1983 Dec;106(6):1399-406. doi: 10.1016/0002-8703(83)90052-2.
- Individual participant dataSharing planned: No
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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.
Luis Raposo, MD principal investigator
Centro Hospitalar de Lisboa Ocidental
Sergio Bravo Baptista, MD, PhD study chair
Hospital Fernando da Fonseca
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fractional Flow Reserve, Myocardial and Coronary Artery Disease, run by Centro Hospitalar Lisboa Ocidental at 6 sites in 4 countries.
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 7 inclusion and 19 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 11 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Portugal, United States, France, 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 Luis Raposo, MD (+351962933777, lfor.md@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of Pd/Pamin vs FFR (time frame: baseline). 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 NCT03237169, which also lists 8 linked publications.
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 11 May 2018.