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

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ClinicalTrials.gov Identifier: NCT01943903
Recruitment Status : Completed
First Posted : September 17, 2013
Last Update Posted : March 23, 2016
Sponsor:
Collaborator:
Duke Clinical Research Institute
Information provided by (Responsible Party):
HeartFlow, Inc.

Tracking Information
First Submitted Date September 10, 2013
First Posted Date September 17, 2013
Last Update Posted Date March 23, 2016
Study Start Date September 2013
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 12, 2013)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01943903 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: September 12, 2013)
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The PLATFORM Study: Prospective LongitudinAl Trial of FFRct: Outcome and Resource IMpacts)
Official Title Prospective LongitudinAl Trial of FFRct: Outcome and Resource IMpacts
Brief Summary 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
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Coronary Artery Disease
Intervention Not Provided
Study 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 21, 2016)
584
Original Estimated Enrollment
 (submitted: September 12, 2013)
580
Actual Study Completion Date December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Austria,   Belgium,   Denmark,   France,   Germany,   Italy,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01943903
Other Study ID Numbers CP-903-003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party HeartFlow, Inc.
Study Sponsor HeartFlow, Inc.
Collaborators 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
PRS Account HeartFlow, Inc.
Verification Date March 2016