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Heartflow (AFFECTS) (AFFECTS)

Primary Purpose

Cardiovascular Abnormalities

Status
Active
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
FFRct and SPECT
Sponsored by
Baylor Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cardiovascular Abnormalities

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • The Heart Hospital Baylor Plano

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

FFRct versus SPECT

Arm Description

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

Outcomes

Primary Outcome Measures

Positive finding of hemodynamically significant CAD according to SPECT.
Positive finding of hemodynamically significant CAD according to FFRct.
Positive finding of hemodynamically significant CAD according to ICA +/- iFFR.

Secondary Outcome Measures

Physician intuition regarding presence of vessel-specific, hemodynamically significant CAD after review of FFRct results.
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.
Potential economic impact of FFRct in decreasing referral to ICA in patients without hemodynamically significant CAD.

Full Information

First Posted
November 22, 2016
Last Updated
March 7, 2022
Sponsor
Baylor Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02973126
Brief Title
Heartflow (AFFECTS)
Acronym
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

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 2016 (undefined)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
July 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baylor Research Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Abnormalities

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
270 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FFRct versus SPECT
Arm Type
Other
Arm Description
Comparison of the diagnostic performance of FFRct and SPECT in subjects with suspected stable CAD
Intervention Type
Procedure
Intervention Name(s)
FFRct and SPECT
Intervention Description
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).
Primary Outcome Measure Information:
Title
Positive finding of hemodynamically significant CAD according to SPECT.
Time Frame
24 months
Title
Positive finding of hemodynamically significant CAD according to FFRct.
Time Frame
24 months
Title
Positive finding of hemodynamically significant CAD according to ICA +/- iFFR.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Physician intuition regarding presence of vessel-specific, hemodynamically significant CAD after review of FFRct results.
Time Frame
24 months
Title
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.
Time Frame
24 months
Title
Potential economic impact of FFRct in decreasing referral to ICA in patients without hemodynamically significant CAD.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Brown, MD
Organizational Affiliation
Baylor Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Heart Hospital Baylor Plano
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Heartflow (AFFECTS)

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