Quantitative 13N-Ammonia Cardiac Rest/Stress Digital PET/CT

Coronary Artery Disease Clinical Trial

Official title:

Quantitative Rest/Stress Cardiac Perfusion Digital PET/CT: Comparison Between Noninvasive Imaging and Invasive Coronary Angiography.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03170817
• Other study ID #: IRB 39331
• Status: Completed
• Start date: March 29, 2017
• Est. completion date: September 1, 2021

Study information

• Verified date: October 2021
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Accurate measurements from a non-invasive test like myocardial perfusion positron emission tomography/ computed tomography (PET/CT) may decrease the need for invasive procedures such as cardiac catheterization.The investigators wish to see if the measurements from cardiac catheterization can be predicted using a non-invasive 13N-NH3 digital PET/CT scan.

Description:

Cardiac imaging using standard-of-care Nuclear Medicine techniques assess the relative radiopharmaceutical distribution from coronary arteries to cardiac tissue. This standard interpretation however, lacks the clinical utility of modern quantitative techniques that are now routinely obtained during cardiac catheterization, such as fractional flow reserve (FFR). Cardiologists routinely base critical management decisions, including the choice for revascularization, stenting, or angioplasty, on these measurements.

Non-invasive measurements of MBF (Myocardial Blood Flow), CFR (Coronary Flow Reserve) and RFR (Relative Flow Reserve) using PET/CT have been investigated, but have yet to reach clinicl use. Given the inherent gains in sensitivity and resolution, digital PET/CT, may allow for a more robust and accurate platform to obtain quantitative measurements of MBF, CFR and RFR which may greatly enhance the clinical utility of cardiac PET/CT for management of coronary artery disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: September 1, 2021
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient is = 18 years old at the time of the scan

• Patient has known or suspected coronary artery disease

• Patient has had a recent or will be scheduled for a diagnostic coronary angiogram

• Patient provides written informed consent

• Patient is referred for myocardial perfusion scan

• Patient is capable of complying with study procedures

• Patient is able to remain still for duration of imaging procedure (approximately 60 minutes total for both PET/CT)

Exclusion Criteria:

• Patients who are pregnant or breast feeding

• Patients with contraindications to regadenoson

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Diagnostic Test:
• Cardiac Perfusion Rest/Stress Digital PET/CT
Patients with coronary artery disease undergo a N-13 ammonia rest/stress PET/CT scan. These patients are given: One 5-10 mCI N13-ammonia (13N-NH3) intravenously and undergo a rest digital PET/CT scan of ~20 minute duration. A dose of 0.4 mg regadenoson (Lexiscan) intravenously over 10 seconds to increase blood flow to the heart One 5-10 mCi N13-ammonia (13N-NH3) intravenously and undergo a stress digital PET/CT scan of ~20 minute duration Total patient time will take approximately up to 120 minutes.

Drug:
• N-13 ammonia
5-10 mCi intravenous injection of N-13 ammonia radiopharmaceutical at rest and at stress
• Regadenoson
0.4 mg/5mL intravenous injection to induce pharmacologic stress (Astellas Pharma US, Inc.)

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	GE Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MBF measurement using PET/CT	Non-invasive measurements of myocardial blood flow (MBF) in milliliter/minute/gram using PET/CT scanner will be compared to invasive cardiac angiography values (current gold standard). MBF values are obtained using image-derived time activity curves from the left ventricular blood and myocardial tissue regions. These values represent radiotracer exchange between the blood and the tissue over time. The rate of radiotracer uptake into the myocardial tissue provides an estimate of MBF. Processing software will then use the time-activity curves to calculate MBF at rest and at stress.	an estimated average of 2 hours
Primary	CFR measurement using PET/CT	Non-invasive measurements of coronary flow reserve (CFR) using digital PET/CT scanner will be compared to the gold standard evaluation from invasive cardiac angiography. Discrepancy between PET measurements and cardiac angiography results will be reported. CFR is the ratio of MBF at peak blood flow to resting MBF.	an estimated average of 2 hours
Primary	RFR measurement using PET/CT	Non-invasive measurements of relative flow reserve (RFR) using digital PET/CT scanner will be compared to the gold standard evaluation from invasive cardiac angiography. Discrepancy between PET measurements and cardiac angiography results will be reported. RFR is the ratio of MBF during stress in an affected region of the left ventricle (LV) to MBF during stress in a normal region of the LV.	an estimated average of 2 hours
Secondary	NM Physician diagnostic confidence of 13N-NH3 PET/CT	Nuclear medicine physician diagnostic confidence will be assessed using a 5-point Likert scale. NM Physicians will compare images obtained from the 13N-NH3 PET/CT to images obtained from single photon emission computed tomography/CT (SPECT/CT).	an estimated average of 2 hours
Secondary	Overall Exam Time	Overall study time as counted from initial administration of radiopharmaceutical to completion of image acquisition will be measured and compared to SPECT/CT overall exam time.	an estimated average of 2 hours
Secondary	Effective radiation dose	Total radiation dose (measured in mSv) from 13N-NH3 PET/CT will be measured and compared to the dose typically given to patients during standard myocardial perfusion imaging SPECT/CT studies.	an estimated average of 2 hours