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The PLATFORM Study: Prospective LongitudinAl Trial of FFRct: Outcome and Resource IMpacts) (PLATFORM)

This study has been completed.
Sponsor:
Collaborator:
Duke Clinical Research Institute
Information provided by (Responsible Party):
HeartFlow, Inc.
ClinicalTrials.gov Identifier:
NCT01943903
First received: September 10, 2013
Last updated: March 21, 2016
Last verified: March 2016
  Purpose
The objective of the PLATFORM Study is to compare clinical outcomes, resource utilization, and quality of life (QOL) of FFRCT-guided evaluation versus standard practice evaluation in patients with suspected CAD in order to further inform patients, health care providers, and other stakeholders about which technologies are most effective and efficient in the diagnosis of CAD

Condition
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective LongitudinAl Trial of FFRct: Outcome and Resource IMpacts

Further study details as provided by HeartFlow, Inc.:

Primary Outcome Measures:
  • Rate of negative invasive coronary angiography [ Time Frame: 90 Days from first test ]
    The primary endpoint of the PLATFORM Study is 90 day (+30/-15 days) rate of coronary angiogram showing no stenosis > 50% in a vessel > 2.0 mm by Quantitative Coronary Angiography (QCA), or no invasively-measured FFR < 0.80 in a segment distal to a stenosis in a vessel > 2.0 mm by QCA between Cohort 1 and 2.


Secondary Outcome Measures:
  • MACE [ Time Frame: 90 days from first test ]

    90 days (+30/-15 days) Cohort 1 and Cohort 2 Major Adverse Coronary Event (MACE) rates, defined as:

    1. All cause death
    2. Non-fatal MI
    3. Unplanned hospitalization for acute coronary syndrome (ACS) leading to urgent revascularization

  • Resource Utilization at 90 Days [ Time Frame: 90 days from first test ]

    Comparison of Resource utilization between cohort 1 and cohort 2 at 90 days (+30/-15 days), a composite from regional standard costs (in Euro) of:

    1. Invasive diagnostic and therapeutic coronary procedures
    2. Targeted medication use
    3. Treatment of MACE Events
    4. Noninvasive cardiac testing
    5. Treatment of vascular events related to invasive diagnostic or therapeutic coronary procedures, occurring within 14 days of invasive procedure

  • Resource Utilization at 180 Days [ Time Frame: 180 days from first test ]

    Comparison of Resource utilization between cohort 1 and cohort 2 at 180 days (+/- 30 days), a composite from regional standard costs (in Euro) of:

    1. Invasive diagnostic and therapeutic coronary procedures
    2. Targeted medication use
    3. Treatment of MACE Events
    4. Noninvasive cardiac testing
    5. Treatment of vascular events related to invasive diagnostic or therapeutic coronary procedures, occurring within 14 days of invasive procedure

  • Resource Utilization at 365 Days [ Time Frame: 365 days from first test ]

    Comparison of Resource utilization between cohort 1 and cohort 2 at 365 days (+/- 30 days), a composite from regional standard costs (in Euro) of:

    1. Invasive diagnostic and therapeutic coronary procedures
    2. Targeted medication use
    3. Treatment of MACE Events
    4. Noninvasive cardiac testing
    5. Treatment of vascular events related to invasive diagnostic or therapeutic coronary procedures, occurring within 14 days of invasive procedure


Enrollment: 584
Study Start Date: September 2013
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cohort 1 - Standard of Care
Subjects will be referred for non-invasive and/or invasive testing and evaluation. Prior to treatment of each subject considered for percutaneous coronary intervention (PCI) and/or coronary artery bypass grafting (CABG), the investigator and the institution's heart team will review clinical data and results of the diagnostic tests to recommend a treatment strategy, according to the institution's standard practice. Cohort 1 of the study is an observational evaluation of resource utilization and outcomes based on standard practice for diagnosis and treatment of subjects with symptomatic suspected CAD and intermediate likelihood of obstructive CAD. Subjects will be followed for one year after enrollment.
Cohort 2 - FFRCT-guided
Subjects will be referred for non-invasive and/or invasive testing and evaluation. Prior to treatment of subjects considered for PCI and/or CABG, the investigator and the institution's heart team will review the results of all available diagnostic tests, including cCTA and FFRCT, and will recommend a treatment strategy accordingly. FFRCT is a non-invasive method to evaluate the hemodynamic significance of coronary artery lesions. FFRCT calculates FFR from subject-specific cCTA data using computational fluid dynamics under rest and simulated maximal coronary hyperemic conditions. FFRCT values range between 0 and 1, and values ≤0.80 are considered hemodynamically (HD)-significant.

Detailed Description:

The OVERALL OBJECTVE of this post-market, multicenter, longitudinal, prospective, consecutive cohort study is to compare clinical outcomes, resource utilization, and quality of life (QOL) in subjects receiving standard practice evaluation and treatment versus subjects receiving FFRCT-guided evaluation and treatment in subjects with suspected CAD in order to further inform patients, health care providers, and other stakeholders about which technologies are most effective and efficient in the diagnosis of CAD. Cohort 1 of this study will assess outcomes incorporating standard practice evaluation and Cohort 2 will assess outcomes incorporating FFRCT-guided evaluation. Each Cohort will be further delineated based upon initial presentation, whereas subjects presenting for initial non-invasive testing will be designated as Cohorts 1A and 2A; and subjects already referred for ICA will be designated as Cohorts 1B and 2B.

SPECIFIC OBJECTIVES for sequential cohort comparisons:

  1. To compare the rate of ICA documenting non-obstructive coronary artery disease, clinical outcomes, and QOL following standard practice for diagnostic and treatment planning modalities in Cohort 1 versus incorporating FFRCT as the preferred test to guide further invasive management and medical treatment in Cohort 2;
  2. To compare resource utilization following standard practice for diagnostic and treatment pathways in Cohort 1 versus incorporating FFRCT as the preferred test to guide further invasive management and medical treatment in Cohort 2;
  3. To provide supporting data for generating new guidelines for diagnosis and prognosis of CAD with comparative analysis of the risk stratification with the Updated Diamond-Forrester risk model (UDF);
  4. To provide society including patients, health care providers and other stakeholders with information about which diagnostic technologies are most effective and efficient in managing patients with CAD.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects referred with intermediate likelihood of obstructive CAD with an Updated Diamond-Forrester (UDF) risk score 20-80% with symptomatic, suspected CAD
Criteria

Inclusion Criteria:

  • Age >18 years
  • Providing written informed consent
  • Subjects with intermediate likelihood of obstructive CAD with an Updated Diamond-Forrester (UDF) risk score 20-80% with symptomatic, suspected CAD who:
  • In Cohort 1A & 2A only are scheduled to undergo initial clinically-indicated non-invasive coronary evaluation, and have not undergone non-invasive coronary evaluation, including exercise tolerance testing, stress echocardiography, SPECT or MRI, or cCTA, within the past 90 days OR ICA at any time; or
  • In Cohort 1B & 2B only have been referred to invasive coronary angiography (ICA) and have not undergone ICA within the past 90 days
  • Ability to undergo cCTA

Exclusion Criteria:

  • Suspicion of acute coronary syndrome. Subjects experiencing unstable angina are not excluded where clinical documentation has ruled out a myocardial infarction.
  • Prior, clinically documented myocardial infarction
  • PCI prior to first test
  • CABG prior to first test
  • Contraindications for cCTA such as:
  • Presence of pacemaker or internal defibrillator leads
  • Atrial Fibrillation
  • Known anaphylactic allergy to iodinated contrast
  • Pregnancy or unknown pregnancy status in women of childbearing potential
  • Body mass index >35 kg/m2
  • Contraindication to acute beta blockade
  • Contraindication to acute sublingual nitrate administration
  • Prosthetic heart valve
  • Contraindications to FFRCT
  • Complex Congenital Heart disease other than anomalous coronary origins alone
  • Ventricular septal defect with known Qp/Qs>1.4
  • Requiring an emergent procedure within 48 hours of presentation
  • Evidence of active clinical instability, including cardiogenic shock, unstable blood pressure with systolic blood pressure <90 mmHg, or NYHA Grade III or IV congestive heart failure or acute pulmonary edema
  • Any active, serious, life-threatening disease with a life expectancy of less than 2 years
  • Inability to comply with study follow-up requirements
  • Current participation in any other clinical trial involving an investigational device or dictating care pathways at the time of enrollment.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01943903

Locations
United States, California
HeartFlow, Inc
Redwood City, California, United States, 94063
Stanford University
Stanford, California, United States, 94305
United States, North Carolina
Duke University Clinical Research Institution
Durham, North Carolina, United States, 27705
Austria
LKH-GRAZ-West - Department of Cardiology
Graz, Austria, A-8020
Innsbruck Medical University, Department of Radiology II
Innsbruck, Austria, A-6020
Belgium
Cardiovascular Center Aalst
Aalst, Belgium
Denmark
Aarhus University Hospital Skejby
Aarhus, Denmark, 8200
France
CHU Brest - Hopital de Cardiologie
Brest, France, 29609
Cardiovascular Hospital -Interventional Cardiology Dept, Hospices Civils de Lyon and Claude Bernard University France
Lyon, France, 69677
Germany
Heart Center Leipzig GmbH
Leipzig, Germany, 04289
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, Germany, 55131
Deutsches Herzzentrum München - ISAResearch Centre
Munich, Germany, 80636
Italy
Centro Cardiologico Monzino
Milan, Italy, 20154
United Kingdom
Freeman Hospital - Therapeutics & Cardiac Research Team
Newcastle upon Tyne, United Kingdom, NE7 7DN
University Hospital Southampton NHS Foundation Trust
Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
HeartFlow, Inc.
Duke Clinical Research Institute
Investigators
Principal Investigator: Gianluca Pontone, MD Centro Cardiologico Monzino
Principal Investigator: Pamela Douglas, MD Duke University
Principal Investigator: Bernard de Bruyne, MD, PHD Cardiovascular Center Aalst
Principal Investigator: Mark Hlatky, MD Stanford University
  More Information