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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02973126
Other study ID # 016-096
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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