Clinical trial NCT02973126: Heartflow (AFFECTS)
Official title: 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: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Cardiovascular Abnormalities
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
First posted: 2016-11-25
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Positive finding of hemodynamically significant CAD according to SPECT.
timeFrame: 24 months
measure: Positive finding of hemodynamically significant CAD according to FFRct.
timeFrame: 24 months
measure: Positive finding of hemodynamically significant CAD according to ICA +/- iFFR.
timeFrame: 24 months
Secondary outcomes:
measure: Physician intuition regarding presence of vessel-specific, hemodynamically significant CAD after review of FFRct results.
timeFrame: 24 months
measure: 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.
timeFrame: 24 months
measure: Potential economic impact of FFRct in decreasing referral to ICA in patients without hemodynamically significant CAD.
timeFrame: 24 months
Other outcomes:
Locations:
city: Plano
country: United States
facility: The Heart Hospital Baylor Plano
state: Texas
Study officials:
affiliation: Baylor Research Institute
name: David Brown, MD
role: PRINCIPAL_INVESTIGATOR
References: