Heartflow (AFFECTS)

Baylor Scott and White Health (BSWH)

Status and phase: Unknown; Phase 3

Conditions: Cardiovascular Abnormalities

Treatments: Procedure: FFRct and SPECT

Study type: Interventional

Funder types: Other

Identifiers

NCT02973126

016-096

Details and patient eligibility

About

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.

Enrollment: 270 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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270 participants in 1 patient group

FFRct versus SPECT

Other group

Description:

Comparison of the diagnostic performance of FFRct and SPECT in subjects with suspected stable CAD

Treatment:

Procedure: FFRct and SPECT