Heartflow (AFFECTS) (AFFECTS)

Assessment of Fractional Flow reservE Computed Tomography Versus Single Photon Emission Computed Tomography in the Diagnosis of Hemodynamically Significant Coronary Artery Disease. (AFFECTS)

The overall objective of the AFFECTS Study is to assess agreement between SPECT and FFRct in identifying vessel-specific, hemodynamically significant CAD in patients scheduled for invasive coronary angiography (ICA) based on abnormal SPECT myocardial perfusion scans. In particular, the study will evaluate the ability of FFRct to correctly rule out hemodynamically significant CAD in patients with non-significant CAD or normal coronary arteries who had positive SPECT scans.

Study Overview

• Status: Active, not recruiting
• Conditions: Cardiovascular Abnormalities
• Intervention / Treatment: Procedure: FFRct and SPECT

• Study Type: Interventional
• Enrollment (Anticipated): 270
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Texas
    • Plano, Texas, United States, 75093
      • The Heart Hospital Baylor Plano

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age ≥ 18 years
• Providing written informed consent
• Subjects with abnormal SPECT myocardial perfusion imaging results who have been referred for clinically indicated ICA within 90-days of SPECT.
• Ability to undergo cCTA

Exclusion Criteria:

• Acute coronary syndrome (ACS).
• Prior, clinically documented, myocardial infarction (MI).
• Prior coronary artery bypass grafting (CABG)
• Prior coronary stenting
• Evidence of ongoing or active clinical instability including unstable angina, intractable arrhythmia, cardiogenic shock, unstable BP, and severe CHF (NYHA class III or IV) or acute pulmonary edema

• Contraindications for cCTA such as:

  1. Presence of pacemaker or internal defibrillator leads such that coronary visualization is impaired
  2. Chronic atrial fibrillation with uncontrolled ventricular response
  3. Known anaphylactic allergy to iodinated contrast that cannot be pre-medicated
  4. Pregnancy or unknown pregnancy status in women of childbearing age
  5. Contraindication to acute beta blockade
  6. Contraindication to acute sublingual nitrate administration
  7. Prosthetic heart valve such that coronary visualization is impaired

• Contraindications for FFRct such as:

  1. Complex congenital heart disease other than anomalous coronary origins alone
  2. Ventricular septal defect with known Qp/Qs > 1.4
• Requiring an emergent procedure within 48 hours of presentation
• Any active, serious, life-threatening disease with life expectancy less than 2 months
• Inability to comply with study procedures
• Current participation in any other clinical trial involving an investigational device, drug, or dictating care pathways at the time of enrollment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: FFRct versus SPECT; Comparison of the diagnostic performance of FFRct and SPECT in subjects with suspected stable CAD	Procedure: FFRct and SPECT; enable the comparison of diagnostic performance of FFRct and SPECT in subjects with suspected stable CAD after abnormal SPECT imaging who have no contraindications to coronary computed tomography angiography (CCTA).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Positive finding of hemodynamically significant CAD according to SPECT.	24 months
Positive finding of hemodynamically significant CAD according to FFRct.	24 months
Positive finding of hemodynamically significant CAD according to ICA +/- iFFR.	24 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Physician intuition regarding presence of vessel-specific, hemodynamically significant CAD after review of FFRct results.	24 months
Cumulative radiation exposure in the study cohort during SPECT, cCTA, and ICA and potential impact of FFRct in reducing radiation exposure in patients with no hemodynamically significant CAD.	24 months
Potential economic impact of FFRct in decreasing referral to ICA in patients without hemodynamically significant CAD.	24 months

Collaborators and Investigators

• Sponsor: Baylor Research Institute
• Investigators: Principal Investigator: David Brown, MD, Baylor Research Institute

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: November 22, 2016
• First Submitted That Met QC Criteria: November 22, 2016
• First Posted (Estimate): November 25, 2016

Study Record Updates

• Last Update Posted (Actual): March 18, 2022
• Last Update Submitted That Met QC Criteria: March 7, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities
• Other Study ID Numbers: 016-096

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No