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

Coronary Artery Disease Clinical Trial

— PLATFORM  

Official title:

Prospective LongitudinAl Trial of FFRct: Outcome and Resource IMpacts

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01943903
• Other study ID #: CP-903-003
• Status: Completed
• Phase: N/A
• First received: September 10, 2013
• Last updated: March 21, 2016
• Start date: September 2013
• Est. completion date: December 2015

Study information

• Verified date: March 2016
• Source: HeartFlow, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of HealthGermany: Ethics CommissionDenmark: Danish Health and Medicines AuthorityUnited Kingdom: National Health ServiceUnited Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 584
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
Austria	LKH-GRAZ-West - Department of Cardiology	Graz
Austria	Innsbruck Medical University, Department of Radiology II	Innsbruck
Belgium	Cardiovascular Center Aalst	Aalst
Denmark	Aarhus University Hospital Skejby	Aarhus
France	CHU Brest - Hopital de Cardiologie	Brest
France	Cardiovascular Hospital -Interventional Cardiology Dept, Hospices Civils de Lyon and Claude Bernard University France	Lyon
Germany	Heart Center Leipzig GmbH	Leipzig
Germany	Universitätsmedizin der Johannes Gutenberg-Universität Mainz	Mainz
Germany	Deutsches Herzzentrum München - ISAResearch Centre	Munich
Italy	Centro Cardiologico Monzino	Milan
United Kingdom	Freeman Hospital - Therapeutics & Cardiac Research Team	Newcastle upon Tyne
United Kingdom	University Hospital Southampton NHS Foundation Trust	Southampton
United States	Duke University Clinical Research Institution	Durham	North Carolina
United States	HeartFlow, Inc	Redwood City	California
United States	Stanford University	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
HeartFlow, Inc.	Duke Clinical Research Institute

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Denmark,  France,  Germany,  Italy,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of negative invasive coronary angiography	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.	90 Days from first test	No
Secondary	MACE	90 days (+30/-15 days) Cohort 1 and Cohort 2 Major Adverse Coronary Event (MACE) rates, defined as: All cause death; Non-fatal MI; Unplanned hospitalization for acute coronary syndrome (ACS) leading to urgent revascularization	90 days from first test	Yes
Secondary	Resource Utilization at 90 Days	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: Invasive diagnostic and therapeutic coronary procedures; Targeted medication use; Treatment of MACE Events; Noninvasive cardiac testing; Treatment of vascular events related to invasive diagnostic or therapeutic coronary procedures, occurring within 14 days of invasive procedure	90 days from first test	No
Secondary	Resource Utilization at 180 Days	Comparison of Resource utilization between cohort 1 and cohort 2 at 180 days (+/- 30 days), a composite from regional standard costs (in Euro) of: Invasive diagnostic and therapeutic coronary procedures; Targeted medication use; Treatment of MACE Events; Noninvasive cardiac testing; Treatment of vascular events related to invasive diagnostic or therapeutic coronary procedures, occurring within 14 days of invasive procedure	180 days from first test	No
Secondary	Resource Utilization at 365 Days	Comparison of Resource utilization between cohort 1 and cohort 2 at 365 days (+/- 30 days), a composite from regional standard costs (in Euro) of: Invasive diagnostic and therapeutic coronary procedures; Targeted medication use; Treatment of MACE Events; Noninvasive cardiac testing; Treatment of vascular events related to invasive diagnostic or therapeutic coronary procedures, occurring within 14 days of invasive procedure	365 days from first test	No