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

October 24, 2021 updated by: Guido A. Davidzon, MD, SM, Stanford University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

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.

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
an estimated average of 2 hours
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.
an estimated average of 2 hours
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.
an estimated average of 2 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
NM Physician diagnostic confidence of 13N-NH3 PET/CT
Time Frame: an estimated average of 2 hours
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
Overall Exam Time
Time Frame: an estimated average of 2 hours
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
Effective radiation dose
Time Frame: an estimated average of 2 hours
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Stanford University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
GE Healthcare

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Guido Davidzon, MD, MS, Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 29, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 26, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 26, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 31, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 26, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB 39331

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

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).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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