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

NCT03170817 | Completed DMC FDA Device

• 1 other identifier: IRB 39331
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (3)

• NM Physician diagnostic confidence of 13N-NH3 PET/CT

  an estimated average of 2 hours

• Overall Exam Time

  an estimated average of 2 hours

• Effective radiation dose

  an estimated average of 2 hours

Study Arms (1)

N13-ammonia Cardiac Rest/Stress PET/CT

Patients with coronary artery disease (CAD) undergo a Cardiac Perfusion Rest/Stress Digital PET/CT scan using the radiopharmaceutical N13-ammonia and Regadenoson (Lexiscan) to induce pharmacologic stress.

Diagnostic Test: Cardiac Perfusion Rest/Stress Digital PET/CT; Drug: N-13 ammonia; Drug: Regadenoson

Interventions

Cardiac Perfusion Rest/Stress Digital PET/CT DIAGNOSTIC_TEST

Patients with coronary artery disease undergo a N-13 ammonia rest/stress PET/CT scan. These patients are given: 1. One 5-10 mCI N13-ammonia (13N-NH3) intravenously and undergo a rest digital PET/CT scan of \~20 minute duration. 2. A dose of 0.4 mg regadenoson (Lexiscan) intravenously over 10 seconds to increase blood flow to the heart 3. 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.

N13-ammonia Cardiac Rest/Stress PET/CT

N-13 ammonia DRUG

5-10 mCi intravenous injection of N-13 ammonia radiopharmaceutical at rest and at stress

N13-ammonia Cardiac Rest/Stress PET/CT

Regadenoson DRUG

0.4 mg/5mL intravenous injection to induce pharmacologic stress (Astellas Pharma US, Inc.)

Also known as: Lexiscan

N13-ammonia Cardiac Rest/Stress PET/CT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Stanford Cardiologists will be aware of this ongoing prospective study. Potential participants will be referred to the study by Stanford Cardiology once they are identified by a cardiologist as having intermediate or high risk for a cardiovascular event.

You may qualify if:

• 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)

You may not qualify if:

• Patients who are pregnant or breast feeding
• Patients with contraindications to regadenoson

Sponsors & Collaborators

• Stanford University: lead
• GE Healthcare: collaborator

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

regadenoson

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Guido Davidzon, MD, MS

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: May 26, 2017
• First Posted: May 31, 2017
• Study Start: March 29, 2017
• Primary Completion: March 31, 2020
• Study Completion: September 1, 2021
• Last Updated: October 26, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)