Performance of a New REsting Pressure Index During Invasive Angiography Compared To Adenosine Hyperemic FFR (PREDICT)

May 9, 2018 updated by: Luis Raposo, Centro Hospitalar Lisboa Ocidental
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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Lille, France
        • Recruiting
        • Department of Cardiology, university hospital
        • Contact:
          • Eric VanBelle, MD
  • Italy
      • Rome, Italy
        • Recruiting
        • Institute of Cardiology, Catholic University of the Sacred Heart
        • Contact:
          • Antonio M Leone, MD
  • Portugal
      • Amadora, Portugal, 2720-276
        • Recruiting
        • Hospital Prof. Doutor Fernando da Fonseca
        • Contact:
          • Sergio B Batista, MD
      • Carnaxide, Portugal, 2790-134
        • Recruiting
        • Centro Hospitalar de Lisboa Ocidental - Hospital de Santa Cruz
        • Contact:
          • Luis Raposo, MD
      • Lisboa, Portugal
        • Recruiting
        • Centro Hospitalar de Lisboa Central (CHLC) - Hospital de Santa Marta
        • Contact:
          • Ruben Ramos, MD
  • United States
    • New York
      • New York, New York, United States, 11576
        • Recruiting
        • St. Francis Hospital The Heart Center
        • Contact:
          • Allen Jeremias, MD
          • Phone Number: 516-390-9640

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  1. Patients undergoing FFR assessment for standard clinical indications, according to individual operator decision.
  2. Age ≥ 18 years.
  3. Provided signed written informed consent for data collection the collection.
  4. De novo coronary artery disease in target vessel.
  5. Single or multiple vessel disease.
  6. 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).
  7. Stenosis deemed amenable for both evaluation with a pressure wire and for potential revascularization.

Exclusion Criteria:

  1. Subjects with restenosis in the target vessel.
  2. Known severe renal insufficiency (examples being but not limited to eGFR <30 ml/kg/min, serum creatinine ≥ 2.5 mg/dL or on dialysis).
  3. Aorto-ostial lesion location within 3 mm of the aorta junction (both right and left).
  4. Vessel(s) and lesion(s) not amenable for evaluation with a PressureWire™ and/or revascularization.
  5. Tandem lesions
  6. 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).
  7. Left ventricular ejection fraction <50%
  8. Known severe left ventricular hypertrophy
  9. Atrial fibrillation or any other significant arrhythmia (including an heart rate <50/min on sinus rhythm)
  10. Systolic blood pressure <90 mmHg.
  11. Any other medical condition that in the opinion of the investigator will interfere with patient safety or study results
  12. Currently participating in another clinical study that interferes with study results.
  13. Pregnant or nursing females
  14. Planned or prior heart transplantation or listed for heart transplant.
  15. 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.
  16. Patients with severe valvular disease
  17. Patients with severe pulmonary disease
  18. Culprit lesions in ACS patients are not to be included nor non-culprit lesions in patients with a recent STEMI undergoing staged procedures.
  19. Patients with a CTO, regardless of the presence and the extent of angiographic collaterals from the target vessel.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Discriminative power of Pd/Pamin and the best cut-off, taking FFR as gold
Time Frame: baseline
ROC analysis using FFR as reference
baseline
Feasibility of Pd/Pamin measurements
Time Frame: Baseline
Description of how often can Pd/Pamin can be measured accurately
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro Hospitalar Lisboa Ocidental

Collaborators

Abbott Medical Devices
Cardiovascular Research Foundation, New York

Investigators

  • Principal Investigator: Luis Raposo, MD, Centro Hospitalar de Lisboa Ocidental
  • Study Chair: Sergio Bravo Baptista, MD, PhD, Hospital Fernando da Fonseca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 28, 2016

Primary Completion (Anticipated)

September 1, 2018

Study Completion (Anticipated)

September 1, 2018

Study Registration Dates

First Submitted

July 31, 2017

First Submitted That Met QC Criteria

July 31, 2017

First Posted (Actual)

August 2, 2017

Study Record Updates

Last Update Posted (Actual)

May 11, 2018

Last Update Submitted That Met QC Criteria

May 9, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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