Coronary Artery Disease
Conditions
Brief summary
The overall purpose of this research study is to identify the disparity in ischemia measurement between fractional flow reserve (FFR) used in the cardiac catheterization laboratory and myocardial perfusion stress- single-photon emission computed tomography (SPECT). This study aims to determine the correlation between simultaneous FFR and SPECT obtained using regadenoson in the catheterization laboratory.
Detailed description
Patients who are previously scheduled for diagnostic coronary angiography will be approached for consent to be part of the study. If the patient is found to have one or two vessel disease and it is planned by the interventional cardiologist that FFR will be used, then the previously consented patient will be deemed appropriate for the study. The standard procedure will be followed for FFR testing using regadenoson. The patient will then receive the standard dose of Tc-99m sestamibi. The interventional cardiologist will proceed with percutaneous coronary intervention (PCI) if appropriate. Patients will proceed to the cardiac catheterization laboratory holding area post procedure. Patients will then be scheduled to be taken to the nuclear cardiology laboratory one to three hours following the coronary angiogram for standard SPECT acquisition. Patients will be monitored for 2-6 hours or overnight as clinically indicated following diagnostic coronary angiography and PCI. Low dose resting myocardial perfusion scanning may be performed the next day if stress myocardial perfusion study was abnormal.
Interventions
RADIATIONSPECT imaging
myocardial perfusion imaging
Sponsors
Astellas Pharma US, Inc.
Prem Soman
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients undergoing clinically-indicated FFR measurement (to determine the hemodynamic significance of intermediate degrees of stenosis) for single or two -vessel epicardial coronary disease during diagnostic coronary angiography for suspected coronary artery disease.
Exclusion criteria
1. Patients with 3-vessel disease 2. Prior coronary artery bypass grafting 3. Patients with second or third- degree atrioventricular block, without a functioning pacemaker 4. Patients who have ingested caffeine-containing products within the past 12 hours.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concordance Between Gated SPECT Perfusion Data (QGS) and Fractional Flow Reserve (FFR) | 24 hours | The concordance will be calculated as the percentage of patients who had an abnormal FFR (\<0.8) and an abnormal SPECT (a perfusion defect on the SPECT) PLUS patients who had a normal FFR (≥ 0.8) and a normal SPECT. concordance= patients with abnormal FFR and abnormal SPECT + patients with normal FFR and normal SPECT/ total no. of patients |
Countries
United States
Participant flow
Recruitment details
Recruitment was significantly affected by COVID-19 and the increasing use of iFR in place of FFR
Participants by arm
| Arm | Count |
|---|---|
| Image Acquisition Arm Subjects who have undergone a clinically indicated fractional flow reserve measurement in the cardiac catheterization laboratory will receive standard dose Tc-99m sestamibi and undergo resting SPECT image acquisition within three hours from end of cardiac catheterization procedure.
SPECT imaging: myocardial perfusion imaging | 27 |
| Total | 27 |
Baseline characteristics
| Characteristic | Image Acquisition Arm | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 17 Participants | — |
| Age, Categorical Between 18 and 65 years | 10 Participants | — |
| Age, Continuous | 66.6 years STANDARD_DEVIATION 10.3 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 27 participants | — |
| Sex: Female, Male Female | 13 Participants | — |
| Sex: Female, Male Male | 14 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 27 |
| other Total, other adverse events | 0 / 27 |
| serious Total, serious adverse events | 0 / 27 |
Outcome results
Primary
Concordance Between Gated SPECT Perfusion Data (QGS) and Fractional Flow Reserve (FFR)
The concordance will be calculated as the percentage of patients who had an abnormal FFR (\<0.8) and an abnormal SPECT (a perfusion defect on the SPECT) PLUS patients who had a normal FFR (≥ 0.8) and a normal SPECT. concordance= patients with abnormal FFR and abnormal SPECT + patients with normal FFR and normal SPECT/ total no. of patients
Time frame: 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Image Acquisition Arm | Concordance Between Gated SPECT Perfusion Data (QGS) and Fractional Flow Reserve (FFR) | 19 Participants |