Study Results
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.
TERMINATED
NA
20 participants
INTERVENTIONAL
2014-03-12
2020-10-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The objective of this study is to compare the differences in blood flow through the arteries of the heart during stress with hypercapnia and adenosine MPI. The imaging will be done using positron emission tomography (PET) with the radioisotope, or tracer, called Rubidium (Rb-82). The Rb-82 is given through a pump, or elution system.
The investigators hypothesize that hypercapnia will induce a stress-to-rest increase in myocardial blood flow by a factor of 2 or more in myocardial regions supplied by non-stenotic arteries in normal volunteers and participants with coronary artery disease.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Minimizing Reperfusion Injury in Patients With Acute Myocardial Infarction
NCT00846378
Hyperbaric Oxygen Therapy in Patients With Chronic Stable Ischemic Heart Disease: An Option for Therapeutic Angiogenesis?
NCT02760394
Rubidium Elution System Performance Testing
NCT02117284
Intra-aortic Balloon Pump in Extensive Myocardial Infarction With Persistent Ischemia
NCT02125526
Regadenoson R-T Perfusion Imaging Trial
NCT00837369
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Myocardial blood flow quantification
The RA-MR™ Virtual Sequential Gas Delivery System. : delivery of CO2 in increasing levels.
Rubidium Elution System: delivery of Rb-82 through an automated pump system for myocardial PET perfusion imaging.
Persantine stress myocardial PET perfusion imaging: as a standard for comparison.
Delivery of precise levels of carbon dioxide with the RA-MR™ Virtual Sequential Gas Delivery System.
All participants will undergo a baseline rest Rb-82 positron emission tomography (PET) myocardial perfusion imaging scan (MPI) with low-dose computed tomography. Following this baseline study, serial Rb-82 PET MPI using a target level of carbon dioxide (CO2) (approximately 60 mmHg (± 3 mmHg)) as a stress agent will be performed. The 60 mmHg level will be repeated following a minimum 10 minute rest. A rest/stress Rb-82 PET MPI will be performed after return to normal CO2 levels (normocapnea) using persantine as the stress agent.
Myocardial perfusion stress testing
Delivery of rubidium radioisotope (Rb-82) using the automated pump/elution system
All participants will undergo a baseline rest Rb-82 positron emission tomography myocardial perfusion imaging scan (PET MPI) with low-dose CT. Following this baseline study, serial Rb-82 PET MPI using three target levels of pulmonary end-tidal carbon dioxide tension (PetCO2) (approximately 60 mmHg (± 3 mmHg)) as a stress agent will be performed. The 60 mmHg level will be repeated following a minimum 10 minute rest. A second rest Rb-82 PET MPI will be performed after return to normocapnea, followed by a pharmacologic persantine stress Rb-82 PET MPI.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Delivery of precise levels of carbon dioxide with the RA-MR™ Virtual Sequential Gas Delivery System.
All participants will undergo a baseline rest Rb-82 positron emission tomography (PET) myocardial perfusion imaging scan (MPI) with low-dose computed tomography. Following this baseline study, serial Rb-82 PET MPI using a target level of carbon dioxide (CO2) (approximately 60 mmHg (± 3 mmHg)) as a stress agent will be performed. The 60 mmHg level will be repeated following a minimum 10 minute rest. A rest/stress Rb-82 PET MPI will be performed after return to normal CO2 levels (normocapnea) using persantine as the stress agent.
Myocardial perfusion stress testing
Delivery of rubidium radioisotope (Rb-82) using the automated pump/elution system
All participants will undergo a baseline rest Rb-82 positron emission tomography myocardial perfusion imaging scan (PET MPI) with low-dose CT. Following this baseline study, serial Rb-82 PET MPI using three target levels of pulmonary end-tidal carbon dioxide tension (PetCO2) (approximately 60 mmHg (± 3 mmHg)) as a stress agent will be performed. The 60 mmHg level will be repeated following a minimum 10 minute rest. A second rest Rb-82 PET MPI will be performed after return to normocapnea, followed by a pharmacologic persantine stress Rb-82 PET MPI.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age ≥ 18 years old
* BMI ≤ 40 kg/m2
* Able and willing to comply with the study procedures
* Written informed consent
* Participants with documented coronary artery disease
* Stable coronary artery disease on a stable medication regime.
* Healthy volunteers without known heart disease
* Low risk of coronary artery disease (CAD)
Exclusion Criteria
* Known second- or third-degree Atrio-ventricular block without pacemaker
* Atrial flutter or atrial fibrillation
* Dyspnea (NYHA III/IV), wheezing asthma or Chronic Obstructive Pulmonary Disease (COPD)
* Coronary artery bypass graft (CABG) surgery within 60 days prior to screening or at any time after consent
* Percutaneous coronary intervention (PCI) within 30 days prior to screening or at any time following consent
* Acute myocardial infarction or acute coronary syndrome within 60 days prior to screening or at any time following consent
* Recent use of dipyridamole, dipyridamole-containing medications (e.g. Aggrenox)
* Known hypersensitivity to adenosine
* Breastfeeding or pregnancy
* Claustrophobia or inability to lie still in a supine position
* Unwillingness or inability to provide informed consent
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ottawa Heart Institute Research Corporation
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Terrence Ruddy
MD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Terrence D Ruddy, MD
Role: PRINCIPAL_INVESTIGATOR
Ottawa Heart Institute Research Corporation
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University Of Ottawa Heart Institute
Ottawa, Ontario, Canada
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
20140012
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.