Heartflow (AFFECTS)

NCT ID: NCT02973126

Last Updated: 2022-03-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 270 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2022-07-31

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.

Conditions

Cardiovascular Abnormalities

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

FFRct versus SPECT

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

Group Type: OTHER

FFRct and SPECT

Intervention Type: 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).

Interventions

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).

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baylor Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Brown, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor Research Institute

Locations

The Heart Hospital Baylor Plano

Plano, Texas, United States

Countries

United States

Other Identifiers

016-096

Identifier Type: -

Identifier Source: org_study_id