The PLATFORM Study: Prospective LongitudinAl Trial of FFRct: Outcome and Resource IMpacts)
Trial ID or NCT#
NCT01943903
Status
NOT RECRUITING
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
Official Title
Prospective LongitudinAl Trial of FFRct: Outcome and Resource IMpacts
Eligibility Criteria
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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.
Investigator(s)
Mark Hlatky, MD
View on ClinicalTrials.gov
