MedDataX Logo

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

NCT ID: NCT03170817

Last Updated: 2021-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-29

Study Completion Date

2021-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Artery Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Cardiac Perfusion Rest/Stress Digital PET/CT

Intervention Type 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.

N-13 ammonia

Intervention Type DRUG

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

Regadenoson

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DIAGNOSTIC_TEST

N-13 ammonia

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

Intervention Type DRUG

Regadenoson

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Lexiscan

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

GE Healthcare

INDUSTRY

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Guido A. Davidzon, MD, SM

Clinical Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Guido Davidzon, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Stanford University

Stanford, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRB 39331

Identifier Type: -

Identifier Source: org_study_id