Heartflow (AFFECTS)

NCT02973126 | Unknown Phase 3 DMC

• 1 other identifier: 016-096
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (3)

• 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.

  24 months

• Potential economic impact of FFRct in decreasing referral to ICA in patients without hemodynamically significant CAD.

  24 months

Study Arms (1)

FFRct versus SPECT

OTHER

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

Procedure: FFRct and SPECT

Interventions

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).

FFRct versus SPECT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• Presence of pacemaker or internal defibrillator leads such that coronary visualization is impaired
• Chronic atrial fibrillation with uncontrolled ventricular response
• Known anaphylactic allergy to iodinated contrast that cannot be pre-medicated
• Pregnancy or unknown pregnancy status in women of childbearing age
• Contraindication to acute beta blockade
• Contraindication to acute sublingual nitrate administration
• Prosthetic heart valve such that coronary visualization is impaired
• Contraindications for FFRct such as:
• Complex congenital heart disease other than anomalous coronary origins alone

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (1)

The Heart Hospital Baylor Plano

Plano, Texas, 75093, United States

Location

MeSH Terms

Conditions

Cardiovascular Abnormalities

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• David Brown, MD

  Baylor Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2016
• First Posted: November 25, 2016
• Study Start: September 1, 2016
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: March 18, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)