Comparison of the Diagnostic Performance and Costs of FFRB Vs. Standard Care in Suspected Coronary Artery Disease.

NCT06681584 | Active Not Recruiting DMC

• 2 other identifiers: ECONOMY2020/2092
• Study Type: observational
• Target: 340
• Locations: 1 country
• Sites: 3

Brief Summary

Chest pain due to coronary artery disease (CAD) is a main driver of healthcare costs. Fractional flow reserve (FFR) measurement during invasive coronary angiography (ICA) is the gold standard to discriminate ischemia. A rapid simplified method had been developed to determine non-invasive FFR (FFRB) by applying computational fluid dynamics (CFD) simulation on anatomic models derived from computed tomographic coronary angiography (CTCA).In this current study, the aims is to compare the diagnostic accuracy, clinical effectiveness, safety outcomes, and quality of life of using FFRB on top of CTCA for CAD diagnosis and treatment planning, versus standard of care in Singapore; and measure health care resource utilization and assess cost-effectiveness of adopting FFRB on top of CTCA to support decision making in managing patients with suspected CAD.

Conditions

Coronary Artery Disease; Cardiovascular Diseases; Cardiovascular; Stenosis; Coronary Occlusion; Coronary Stenosis; Heart Diseases; Vascular Diseases; Constriction, Pathologic; Pathological Conditions, Anatomical

Keywords

CT angiogram; Fractional flow reserve; Coronary disease; Coronary stenosis; Coronary plaque

Outcome Measures

Primary Outcomes (1)

• Compare the diagnostic performance of FFRB vs. standard care in suspected coronary artery disease.

  The outcome is the rate of invasive coronary angiography.

  1 year for each enrolled subject

Secondary Outcomes (1)

• Compare the total costs based on FFRB compared with standard care in suspected coronary artery disease.

  1 year for each enrolled subject

Study Arms (2)

Group A

Both groups of patients will receive CT scan for calcium score and Coronary angiogram, viz CTCA scan. Non-invasive FFRb will be calculated for all the patients with acceptable CTCA image quality. Based on the medical history and CTCA results, the patients may be referred for additional non-invasive tests or ICA and treated with medical therapy, PCI or CABG

Diagnostic Test: CTCA

Group B

Both groups of patients will receive CT scan for calcium score and Coronary angiogram, viz CTCA scan. Non-invasive FFRb will be calculated for all the patients with acceptable CTCA image quality. However the FFRb results will only be given to the doctors who are taking care of the patients in Group B. Based on the medical history and CTCA with FFRb results (Group B), the patients may be referred for additional non-invasive tests or ICA and treated with medical therapy, PCI or CABG

Diagnostic Test: CTCA

Interventions

CTCA DIAGNOSTIC_TEST

CTCA is a non-invasive test for diagnosis of anatomic coronary stenosis. Additionally, the diagnostic performance of FFRB (derived from in house calculation) with CCTA data in patients with intermediate coronary artery disease (CAD), as compared to an invasive FFR reference standard (FFR\<=0.80)

Group A; Group B

Eligibility Criteria

• Age: 21 Years - 98 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with intermediate likelihood of obstructive CAD and with symptomatic suspected CAD who 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 CTCA within the past 90 days OR ICA at any time.

You may qualify if:

• Aged 21 to 98
• Providing written informed consent
• Subjects with intermediate likelihood of obstructive CAD and with symptomatic suspected CAD who 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 CTCA within the past 90 days OR ICA at any time.

You may not qualify if:

• Suspicion of acute coronary syndrome. Subjects experiencing unstable angina are not excluded where clinical documentation has ruled out myocardial infarctions.
• Prior, clinically documented myocardial infarction
• PCI prior to first test
• Coronary artery bypass grafting (CABG) prior to first test
• Contraindications for CTCA 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\> 35kg/m2
• Contraindication to acute beta blockade

Sponsors & Collaborators

• National Heart Centre Singapore: lead

Study Sites (3)

National University Hospital

Singapore, 119074, Singapore

Location

National Heart Centre Singapore

Singapore, 169609, Singapore

Location

Tan Tock Seng Hospital

Singapore, 308433, Singapore

Location

Biospecimen

Retention: SAMPLES WITH DNA

EDTA Platelet Poor Plasma , Sodium Citrate Platelet Poor Plasma and EDTA buffy coat

MeSH Terms

Conditions

Coronary Artery Disease; Cardiovascular Diseases; Constriction, Pathologic; Coronary Occlusion; Coronary Stenosis; Heart Diseases; Vascular Diseases; Pathological Conditions, Anatomical; Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Pathological Conditions, Signs and Symptoms

Study Officials

• Dr Lohendran Baskaran

  lohendran.baskaran@singhealth.com.sg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2022
• First Posted: November 8, 2024
• Study Start: October 1, 2021
• Primary Completion: May 31, 2024
• Study Completion: May 1, 2025
• Last Updated: November 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

SG (3)