Heartflow (AFFECTS)

Cardiovascular Abnormalities Clinical Trial

— 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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02973126
• Other study ID #: 016-096
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: September 2016
• Est. completion date: July 2022

Study information

• Verified date: February 2022
• Source: Baylor Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 270
• Est. completion date: July 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Abnormalities

Intervention

Procedure:
• 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).

Locations

Country	Name	City	State
United States	The Heart Hospital Baylor Plano	Plano	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive finding of hemodynamically significant CAD according to SPECT.		24 months
Primary	Positive finding of hemodynamically significant CAD according to FFRct.		24 months
Primary	Positive finding of hemodynamically significant CAD according to ICA +/- iFFR.		24 months
Secondary	Physician intuition regarding presence of vessel-specific, hemodynamically significant CAD after review of FFRct results.		24 months
Secondary	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
Secondary	Potential economic impact of FFRct in decreasing referral to ICA in patients without hemodynamically significant CAD.		24 months