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

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

Study Description

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

Condition or disease
Coronary Artery Disease

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 Design

• Study Type: Observational
• Actual Enrollment: 584 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Prospective LongitudinAl Trial of FFRct: Outcome and Resource IMpacts
• Study Start Date: September 2013
• Actual Primary Completion Date: December 2015
• Actual Study Completion Date: December 2015

Groups and Cohorts

Group/Cohort
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.

Outcome Measures

Primary Outcome Measures :

1. 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 :

1. 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
2. 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
3. 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
4. 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• 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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Douglas PS, De Bruyne B, Pontone G, Patel MR, Norgaard BL, Byrne RA, Curzen N, Purcell I, Gutberlet M, Rioufol G, Hink U, Schuchlenz HW, Feuchtner G, Gilard M, Andreini D, Jensen JM, Hadamitzky M, Chiswell K, Cyr D, Wilk A, Wang F, Rogers C, Hlatky MA; PLATFORM Investigators. 1-Year Outcomes of FFRCT-Guided Care in Patients With Suspected Coronary Disease: The PLATFORM Study. J Am Coll Cardiol. 2016 Aug 2;68(5):435-445. doi: 10.1016/j.jacc.2016.05.057.

Hlatky MA, De Bruyne B, Pontone G, Patel MR, Norgaard BL, Byrne RA, Curzen N, Purcell I, Gutberlet M, Rioufol G, Hink U, Schuchlenz HW, Feuchtner G, Gilard M, Andreini D, Jensen JM, Hadamitzky M, Wilk A, Wang F, Rogers C, Douglas PS; PLATFORM Investigators. Quality-of-Life and Economic Outcomes of Assessing Fractional Flow Reserve With Computed Tomography Angiography: PLATFORM. J Am Coll Cardiol. 2015 Dec 1;66(21):2315-2323. doi: 10.1016/j.jacc.2015.09.051. Epub 2015 Oct 14.

• Responsible Party: HeartFlow, Inc.
• ClinicalTrials.gov Identifier: NCT01943903 History of Changes
• Other Study ID Numbers: CP-903-003
• First Posted: September 17, 2013
• Last Update Posted: March 23, 2016
• Last Verified: March 2016

Additional relevant MeSH terms:

Coronary Artery Disease; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases