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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FFRct versus SPECT | Other | Comparison of the diagnostic performance of FFRct and SPECT in subjects with suspected stable CAD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FFRct and SPECT | Procedure | 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). |
| 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 |
| 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. |
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Inclusion Criteria:
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:
Contraindications for FFRct such as:
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
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| Name | Affiliation | Role |
|---|---|---|
| David Brown, MD | Baylor Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Heart Hospital Baylor Plano | Plano | Texas | 75093 | United States |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 17, 2026 | |
| Reset | Apr 3, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 17, 2026 | Apr 3, 2026 | |||
| Jun 24, 2026 |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| 24 months |
| Potential economic impact of FFRct in decreasing referral to ICA in patients without hemodynamically significant CAD. | 24 months |