Cardiovascular AbnormalitiesPhase 3AFFECTSNCT02973126
Heartflow (AFFECTS)
A Phase 3 study testing FFRct and SPECT in people with Cardiovascular Abnormalities, run by Baylor Research Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Abnormalities
- What is being tested?
- FFRct and SPECT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to Jul 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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:
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
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
- Being tested
- FFRct and SPECT
- Medical subject headings
- Cardiovascular Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FFRct and SPECTProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| FFRct versus SPECT | Other | Comparison of the diagnostic performance of FFRct and SPECT in subjects with suspected stable CAD Receives: Procedure: FFRct and SPECT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive finding of hemodynamically significant CAD according to SPECT.
Measured: 24 months
Positive finding of hemodynamically significant CAD according to FFRct.
Measured: 24 months
Positive finding of hemodynamically significant CAD according to ICA +/- iFFR.
Measured: 24 months
Secondary outcomes (3)
Physician intuition regarding presence of vessel-specific, hemodynamically significant CAD after review of FFRct results.
Measured: 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.
Measured: 24 months
Potential economic impact of FFRct in decreasing referral to ICA in patients without hemodynamically significant CAD.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2016 (estimated)
- Study startSep 2016
- Primary completionJul 2022 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular AbnormalitiesStudies of the same condition, open and under way.
- More trials run by Baylor Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Brown, MD, Principal investigator, Baylor Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02973126
- Sponsor's protocol ID
- 016-096
- Acronym
- AFFECTS
- Status last verified
- Feb 2022
- First submitted
- 22 Nov 2016
- Last updated
- 18 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02973126
- Acronym / sponsor ID
- AFFECTS / 016-096
- Conditions
- Cardiovascular Abnormalities
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 25 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FFRct versus SPECT | Other | Procedure: FFRct and SPECTComparison of the diagnostic performance of FFRct and SPECT in subjects with suspected stable CAD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FFRct and SPECTenable 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). | Procedure or surgery | FFRct versus SPECT |
Primary outcome
Positive finding of hemodynamically significant CAD according to SPECT.
Time frame: 24 months
Positive finding of hemodynamically significant CAD according to FFRct.
Time frame: 24 months
Positive finding of hemodynamically significant CAD according to ICA +/- iFFR.
Time frame: 24 months
3 secondary outcomes
Physician intuition regarding presence of vessel-specific, hemodynamically significant CAD after review of FFRct results.
Time frame: 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.
Time frame: 24 months
Potential economic impact of FFRct in decreasing referral to ICA in patients without hemodynamically significant CAD.
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Brown, MD principal investigator
Baylor Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing FFRct and SPECT in people with Cardiovascular Abnormalities, run by Baylor Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive finding of hemodynamically significant CAD according to SPECT. (time frame: 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2022.