Clinical trial NCT01943903: The PLATFORM Study: Prospective LongitudinAl Trial of FFRct: Outcome and Resource IMpacts)
Official title: Prospective LongitudinAl Trial of FFRct: Outcome and Resource IMpacts
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Lead sponsor: HeartFlow, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Duke Clinical Research Institute
First posted: 2013-09-17
Enrollment: 584
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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.

Primary outcomes:
measure: Rate of negative invasive coronary angiography
timeFrame: 90 Days from first test
Secondary outcomes:
measure: MACE
timeFrame: 90 days from first test
measure: Resource Utilization at 90 Days
timeFrame: 90 days from first test
measure: Resource Utilization at 180 Days
timeFrame: 180 days from first test
measure: Resource Utilization at 365 Days
timeFrame: 365 days from first test
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: HeartFlow, Inc
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Durham
country: United States
facility: Duke University Clinical Research Institution
state: North Carolina
city: Graz
country: Austria
facility: LKH-GRAZ-West - Department of Cardiology
city: Innsbruck
country: Austria
facility: Innsbruck Medical University, Department of Radiology II
city: Aalst
country: Belgium
facility: Cardiovascular Center Aalst
city: Aarhus
country: Denmark
facility: Aarhus University Hospital Skejby
city: Brest
country: France
facility: CHU Brest - Hopital de Cardiologie
city: Lyon
country: France
facility: Cardiovascular Hospital -Interventional Cardiology Dept, Hospices Civils de Lyon and Claude Bernard University France
city: Leipzig
country: Germany
facility: Heart Center Leipzig GmbH
city: Mainz
country: Germany
facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz
city: Munich
country: Germany
facility: Deutsches Herzzentrum München - ISAResearch Centre
city: Milan
country: Italy
facility: Centro Cardiologico Monzino
city: Newcastle upon Tyne
country: United Kingdom
facility: Freeman Hospital - Therapeutics & Cardiac Research Team
city: Southampton
country: United Kingdom
facility: University Hospital Southampton NHS Foundation Trust
Study officials:
affiliation: Centro Cardiologico Monzino
name: Gianluca Pontone, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Pamela Douglas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cardiovascular Center Aalst
name: Bernard de Bruyne, MD, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Mark Hlatky, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.