Heartflow (AFFECTS)

Overview

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.

Full Title of Study: “Assessment of Fractional Flow reservE Computed Tomography Versus Single Photon Emission Computed Tomography in the Diagnosis of Hemodynamically Significant Coronary Artery Disease. (AFFECTS)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2022

Interventions

  • 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).

Arms, Groups and Cohorts

  • Other: FFRct versus SPECT
    • Comparison of the diagnostic performance of FFRct and SPECT in subjects with suspected stable CAD

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Physician intuition regarding presence of vessel-specific, hemodynamically significant CAD after review of FFRct results.
    • Time Frame: 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.
    • Time Frame: 24 months
  • Potential economic impact of FFRct in decreasing referral to ICA in patients without hemodynamically significant CAD.
    • Time Frame: 24 months

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Baylor Research Institute
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • David Brown, MD, Principal Investigator, Baylor Research Institute

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.