Heartflow (AFFECTS)

Study Overview
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Brief Summary
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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.

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

Conditions
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Cardiovascular Abnormalities

Intervention / Treatment
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* Procedure: FFRct and SPECT


Participation Criteria
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Eligibility Criteria
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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: Presence of pacemaker or internal defibrillator leads such that coronary visualization is impaired Chronic atrial fibrillation with uncontrolled ventricular response Known anaphylactic allergy to iodinated contrast that cannot be pre-medicated Pregnancy or unknown pregnancy status in women of childbearing age Contraindication to acute beta blockade Contraindication to acute sublingual nitrate administration Prosthetic heart valve such that coronary visualization is impaired Contraindications for FFRct such as: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: FFRct versus SPECT<br>Comparison of the diagnostic performance of FFRct and SPECT in subjects with suspected stable CAD | Procedure: FFRct and SPECT<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 |