Coronary Artery DiseaseNCT03170817
Quantitative 13N-Ammonia Cardiac Rest/Stress Digital PET/CT
An observational study of Coronary Artery Disease, run by Stanford University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Cardiac Perfusion Rest/Stress Digital PET/CT, N-13 ammonia and Regadenoson
- Type of treatment
- Injection or infusion
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Mar 2017to 1 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- Patients who are pregnant or breast feeding
- Patients with contraindications to regadenoson
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quantitative Rest/Stress Cardiac Perfusion Digital PET/CT: Comparison Between Noninvasive Imaging and Invasive Coronary Angiography.
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.
Read the detailed 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Cardiac Perfusion Rest/Stress Digital PET/CT, N-13 ammonia, Regadenoson
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Perfusion Rest/Stress Digital PET/CTDiagnostic test
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.
N-13 ammoniaDrug
5-10 mCi intravenous injection of N-13 ammonia radiopharmaceutical at rest and at stress
RegadenosonDrug
Also called Lexiscan
0.4 mg/5mL intravenous injection to induce pharmacologic stress (Astellas Pharma US, Inc.)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Cardiac Perfusion Rest/Stress Digital PET/CT; Drug: N-13 ammonia; Drug: Regadenoson |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: an estimated average of 2 hours
Secondary outcomes (3)
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).
Measured: an estimated average of 2 hours
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.
Measured: an estimated average of 2 hours
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.
Measured: an estimated average of 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2017
- Study start29 Mar 2017
- Primary completion31 Mar 2020
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- GE Healthcare
- Responsible party
- Principal investigator, Guido A. Davidzon, MD, SM, Stanford University
- Investigators
- Guido Davidzon, MD, MS, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03170817
- Sponsor's protocol ID
- IRB 39331
- Status last verified
- Oct 2021
- First submitted
- 26 May 2017
- Last updated
- 26 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: GE Healthcare is the monitoring entity because GE Healthcare is the Study Sponsor. The monitoring visits will be conducted by a GE Clinical Research Associate (CRA).
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Rest/Stress Cardiac Perfusion Digital PET/CT: Comparison Between Noninvasive Imaging and Invasive Coronary Angiography.
- ClinicalTrials.gov ID
- NCT03170817
- Acronym / sponsor ID
- IRB 39331
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- GE Healthcare
- Study start
- 29 Mar 2017 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 31 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| N13-ammonia Cardiac Rest/Stress PET/CT | – | Diagnostic Test: Cardiac Perfusion Rest/Stress Digital PET/CT, Drug: N-13 ammonia, Drug: RegadenosonPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- Patients who are pregnant or breast feeding
- Patients with contraindications to regadenoson
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac Perfusion Rest/Stress Digital PET/CTPatients 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. | Diagnostic test | N13-ammonia Cardiac Rest/Stress PET/CT |
| N-13 ammonia5-10 mCi intravenous injection of N-13 ammonia radiopharmaceutical at rest and at stress | Drug | N13-ammonia Cardiac Rest/Stress PET/CT |
| RegadenosonAlso: Lexiscan0.4 mg/5mL intravenous injection to induce pharmacologic stress (Astellas Pharma US, Inc.) | Drug | N13-ammonia Cardiac Rest/Stress PET/CT |
Primary outcome
MBF measurement using PET/CT
Time frame: an estimated average of 2 hours
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.
CFR measurement using PET/CT
Time frame: an estimated average of 2 hours
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.
RFR measurement using PET/CT
Time frame: an estimated average of 2 hours
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.
3 secondary outcomes
NM Physician diagnostic confidence of 13N-NH3 PET/CT
Time frame: an estimated average of 2 hours
Overall Exam Time
Time frame: an estimated average of 2 hours
Effective radiation dose
Time frame: an estimated average of 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2021.
- Individual participant dataSharing planned: No. GE Healthcare is the monitoring entity because GE Healthcare is the Study Sponsor. The monitoring visits will be conducted by a GE Clinical Research Associate (CRA).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guido Davidzon, MD, MS principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MBF measurement using PET/CT (time frame: an estimated average of 2 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2021.