The Computed Tomography-derived Fractional Flow Reserve STAT Trial

NCT03263806 | Terminated Results DMC FDA Device

• 1 other identifier: 2017-272
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to directly compare Standard Care and CT fractional flow reserve (CTFFR) for diagnosis of chest pain patients with definite coronary artery disease (CAD) on heart computed tomography (CT) scans.

Conditions

Heart Disease, Coronary; Chest Pain; Acute Coronary Syndrome

Keywords

angina; coronary artery disease; coronary artery catheterization; coronary CT angiography; fractional flow reserve CT; emergency department

Outcome Measures

Primary Outcomes (1)

• Catheterization Rate

  Percent of patients undergoing heart catheterization

  3 months after initial presentation

Secondary Outcomes (3)

• Diagnostic Effectiveness

  3 months after initial presentation

• Incidence of Major Adverse Cardiac Events

  1 year after presentation

• Hospital Length of Stay

  An average of 2 days

Study Arms (2)

SOC Group Management

ACTIVE COMPARATOR

Attending physicians will dictate SOC management according to their own clinical judgment for medical management, stress test plus imaging or coronary artery catheterization with invasive fractional flow reserve.

Diagnostic Test: SOC Group Management

CTFFR-Guided Group Management

EXPERIMENTAL

Patients in this group will be triaged using CTFFR. CTFFR values will be provided to physicians with recommendations for medical management or coronary artery catheterization with invasive fractional flow reserve.

Diagnostic Test: CTFFR-Guided Group Management

Interventions

CTFFR-Guided Group Management DIAGNOSTIC_TEST

Patients will receive standard of care CT on enrollment which will be analyzed by CTFFR. Results will be communicated to the provider who will use CTFFR interpretation to guide care pathway.

Also known as: Computed tomography - fractional flow reserve

CTFFR-Guided Group Management

SOC Group Management DIAGNOSTIC_TEST

Patients will receive standard of care CT on enrollment which will be analyzed by CTFFR. Results are NOT communicated to the provider who will dictate patient management according to their own clinical judgment

SOC Group Management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Emergency department chest pain suspicious for ACS based on history and physical examination.
• At least one biomarker (troponin) and electrocardiogram with no evidence of definite ACS.
• A completed CCTA demonstrating \>50% but \<90% stenosis of at least one coronary artery branch.
• CCTA test images with sufficient diagnostic quality for CTFFR analysis.
• Ability and willingness to provide informed consent.

You may not qualify if:

• Left main coronary stenosis of 50% or greater.
• CCTA lesions demonstrating stenosis \>90% ("subtotal"), or complex, high-risk plaque characteristics resulting in an a priori recommendation for triage to CATH by the CCTA interpreting physician.
• Attending physician a priori decision for CATH.
• Previous coronary stent, coronary bypass or prior known myocardial infarction.
• Clinical instability, such as hypotension, signs of shock, and/or accelerating chest pain requiring admission.
• Pregnancy

Sponsors & Collaborators

• Corewell Health East: lead

Study Sites (1)

Beaumont Health System - Royal Oak

Royal Oak, Michigan, 48073, United States

Location

MeSH Terms

Conditions

Coronary Disease; Chest Pain; Acute Coronary Syndrome; Angina Pectoris; Coronary Artery Disease; Emergencies

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arteriosclerosis; Arterial Occlusive Diseases; Disease Attributes; Pathologic Processes

Limitations and Caveats

Study terminated early due to difficulty of enrollment.

Results Point of Contact

• Title: Korana Stakich-Alpirez
• Organization: Beaumont Hospitals

Korana.Stakich-Alpirez@beaumont.org

248 898 0315

Study Officials

• Gilbert Raff, MD

  Beaumont Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Cardiac MRI/CT

Study Record Dates

• First Submitted: August 24, 2017
• First Posted: August 28, 2017
• Study Start: August 24, 2017
• Primary Completion: April 4, 2018
• Study Completion: April 4, 2018
• Last Updated: July 3, 2018
• Results First Posted: July 3, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)