An interventional study of SPECT imaging in Coronary Artery Disease, sponsored by Prem Soman. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-02.
Sponsored by Prem Soman · Not applicable, Interventional, and Diagnostic
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.
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.
5,676 studies on the registry are indexed under Coronary Artery Disease; 958 are open to participants now.
This study's enrollment of 27 is below the median of 123 across 3,481 interventional studies indexed under Coronary Artery Disease.
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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:
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.
Radiation: SPECT imaging
myocardial perfusion imaging
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
Recruitment was significantly affected by COVID-19 and the increasing use of iFR in place of FFR
| Milestone | Image Acquisition Arm |
|---|---|
| Started | 27 |
| Completed | 27 |
| Not completed | 0 |
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
| Participants | Image Acquisition Arm |
|---|---|
| Concordance Between Gated SPECT Perfusion Data (QGS) and Fractional Flow Reserve (FFR) | 19 |
Collected over Adverse events related to Tc-99m sestamibi SPECT occurring during the patient's stay in the nuclear lab (3-4 hours) were recorded.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Image Acquisition Arm | 0/27 (0%) | 0/27 (0%) | 0/27 (0%) |
| Age, Categorical(Participants) | Image Acquisition Arm |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 10 |
| >=65 years | 17 |
| Age, Continuous(years) | Image Acquisition Arm |
|---|---|
| Mean | 66.6 ± 10.3 |
| Sex: Female, Male(Participants) | Image Acquisition Arm |
|---|---|
| Female | 13 |
| Male | 14 |
| Race and Ethnicity Not Collected(Participants) | Image Acquisition Arm |
|---|
| Region of Enrollment(participants) | Image Acquisition Arm |
|---|---|
| United States | 27 |
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This study is terminated, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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