Coronary Artery DiseaseCO2 STRESSNCT02043535
CO2 as a Stress Agent for Perfusion Imaging
A study testing Delivery of precise levels of carbon dioxide with the RA-MR™ Virtual Sequential Gas Delivery System. and Delivery of rubidium radioisotope (Rb-82) using the automated pump/elution system in people with Coronary Artery Disease, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
Trial summary
Myocardial perfusion imaging (MPI) is a nuclear scan using a radioisotope to see blood flow to the muscles of the heart when the heart is at rest and when it is under stress. The stress test in MPI can be done using medications, such as persantine, that dilate coronary arteries and increase blood flow. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Delivery of precise levels of carbon dioxide with the RA-MR™ Virtual Sequential Gas Delivery System. and Delivery of rubidium radioisotope (Rb-82) using the automated pump/elution system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 12 Mar 2014to 15 Oct 2020
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For all participants
- 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
Show all 9Show fewer
- Stable coronary artery disease on a stable medication regime.
- Healthy volunteers without known heart disease
- Low risk of coronary artery disease (CAD)
Who cannot join
- History or risk of severe bradycardia (heart rate < 50 beats per minute) not related to chronotropic drugs
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Controlled Hypercapnic Stimulation on Myocardial Blood Flow Measured With Positron Emission Tomography
Myocardial perfusion imaging (MPI) is a nuclear scan using a radioisotope to see blood flow to the muscles of the heart when the heart is at rest and when it is under stress. The stress test in MPI can be done using medications, such as persantine, that dilate coronary arteries and increase blood flow. Similarly, elevated carbon dioxide (CO2) levels in the blood, or hypercapnia, also dilates arteries and increases blood flow. Thornhill Research Inc. has developed the RA-MR™ sequential gas delivery system used to control CO2 levels in the blood. The RA-MR™ can deliver precise amounts of CO2 through a mouthpiece for inhalation to increase CO2 levels in the blood and thereby increasing blood flow like during stress.
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.
- Conditions
- Coronary Artery Disease
- Being tested
- Delivery of precise levels of carbon dioxide with the RA-MR™ Virtual Sequential Gas Delivery System., Delivery of rubidium radioisotope (Rb-82) using the automated pump/elution system
- Keywords
- myocardial perfusion imaging, myocardial blood flow, pharmacologic stress agents, carbon dioxide, rubidium 82 radioisotope, positron emission tomography
- 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.
Delivery of precise levels of carbon dioxide with the RA-MR™ Virtual Sequential Gas Delivery System.Device
Also called the RA-MR™ 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 systemDevice
Also called Ruby-Fill™
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.
| Study group | Role | What they receive |
|---|---|---|
| Myocardial blood flow quantification | Other | 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. Receives: Device: Delivery of precise levels of carbon dioxide with the RA-MR™ Virtual Sequential Gas Delivery System.; Device: Delivery of rubidium radioisotope (Rb-82) using the automated pump/elution system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial blood flow differences
The myocardial blood flow (MBF) will be quantified with each Rb-82 PET scan done. Polar-maps representing MBF are generated for each rest and stress state using in-house FlowQuant©software. The rest scan will be the baseline. The myocardial blood flow in the four stress scans using hypercapnia as a stress agent will be compared to the rest baseline myocardial blood flow and the adenosine stress scan myocardial blood flow.
Measured: Difference between baseline rest scan blood flow and hypercapnia stress scan myocardial blood flow at 50 mmHg, 55 mmHg, 60 mmHg levels from baseline. Imaging and intervention analysis will be complete in 4 years.
Secondary outcomes (2)
Absolute myocardial blood flow differences between end-tidal CO2 scans
The effect of increasing doses of pulmonary end-tidal carbon dioxide tension (PetCO2) will be measured and quantification of absolute myocardial blood flow using Rb-82 PET will be calculated. Polar-maps representing MBF are generated for each stress state using in-house FlowQuant©software. Five levels will be measured.
Measured: Difference between baseline and 60 mmHg PetCO2. Imaging and intervention analysis will be complete in 4 years.
Difference bewteen absolute myocardial blood flow with hypercapnia and with adenosine stress.
The effects of hypercapnia and adenosine on absolute myocardial blood flow using Rb-82 PET will be compared. Polar-maps representing MBF are generated for each stress state using in-house FlowQuant©software.
Measured: Quantification and comparison of the differences in myocardial blood flow with adenosine stress and increasing levels of CO2 as a stress agent. Imaging and intervention analysis will be complete in 4 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2014 (estimated)
- Study start12 Mar 2014
- Primary completion15 Oct 2020
- Study completion15 Oct 2020
Why it stopped: The complexity of the study and the recent slow down situation hampered the ability to recruit CAD patients therefore the study has been terminated.
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Terrence Ruddy, Ottawa Heart Institute Research Corporation
- Investigators
- Terrence D Ruddy, MD, Principal investigator, Ottawa Heart Institute Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02043535
- Sponsor's protocol ID
- 20140012
- Acronym
- CO2 STRESS
- Status last verified
- Mar 2021
- First submitted
- 3 Jan 2014
- Last updated
- 2 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Controlled Hypercapnic Stimulation on Myocardial Blood Flow Measured With Positron Emission Tomography
- ClinicalTrials.gov ID
- NCT02043535
- Acronym / sponsor ID
- CO2 STRESS / 20140012
- Conditions
- Coronary Artery Disease
- Keywords
- myocardial perfusion imaging, myocardial blood flow, pharmacologic stress agents, carbon dioxide, rubidium 82 radioisotope, positron emission tomography
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The complexity of the study and the recent slow down situation hampered the ability to recruit CAD patients therefore the study has been terminated.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Study start
- 12 Mar 2014 (actual)
- Primary completion
- 15 Oct 2020 (actual)
- Study completion
- 15 Oct 2020 (actual)
- First posted
- 23 Jan 2014 (estimated)
- 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.
Myocardial perfusion imaging (MPI) is a nuclear scan using a radioisotope to see blood flow to the muscles of the heart when the heart is at rest and when it is under stress. The stress test in MPI can be done using medications, such as persantine, that dilate coronary arteries and increase blood flow. Similarly, elevated carbon dioxide (CO2) levels in the blood, or hypercapnia, also dilates arteries and increases blood flow. Thornhill Research Inc. has developed the RA-MR™ sequential gas delivery system used to control CO2 levels in the blood. The RA-MR™ can deliver precise amounts of CO2 through a mouthpiece for inhalation to increase CO2 levels in the blood and thereby increasing blood flow like during stress.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Myocardial blood flow quantification | Other | Device: Delivery of precise levels of carbon dioxide with the RA-MR™ Virtual Sequential Gas Delivery System., Device: Delivery of rubidium radioisotope (Rb-82) using the automated pump/elution systemThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- For all participants
- Age ≥ 18 years old
- BMI ≤ 40 kg/m2
- Able and willing to comply with the study procedures
- Written informed consent
Key exclusion criteria (12 listed)
- History or risk of severe bradycardia (heart rate < 50 beats per minute) not related to chronotropic drugs
- 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
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 |
|---|---|---|
| Delivery of precise levels of carbon dioxide with the RA-MR™ Virtual Sequential Gas Delivery System.Also: the RA-MR™ SystemAll 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 | Device | Myocardial blood flow quantification |
| Delivery of rubidium radioisotope (Rb-82) using the automated pump/elution systemAlso: Ruby-Fill™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. | Device | Myocardial blood flow quantification |
Primary outcome
Myocardial blood flow differences
Time frame: Difference between baseline rest scan blood flow and hypercapnia stress scan myocardial blood flow at 50 mmHg, 55 mmHg, 60 mmHg levels from baseline. Imaging and intervention analysis will be complete in 4 years.
The myocardial blood flow (MBF) will be quantified with each Rb-82 PET scan done. Polar-maps representing MBF are generated for each rest and stress state using in-house FlowQuant©software. The rest scan will be the baseline. The myocardial blood flow in the four stress scans using hypercapnia as a stress agent will be compared to the rest baseline myocardial blood flow and the adenosine stress scan myocardial blood flow.
2 secondary outcomes
Absolute myocardial blood flow differences between end-tidal CO2 scans
Time frame: Difference between baseline and 60 mmHg PetCO2. Imaging and intervention analysis will be complete in 4 years.
Difference bewteen absolute myocardial blood flow with hypercapnia and with adenosine stress.
Time frame: Quantification and comparison of the differences in myocardial blood flow with adenosine stress and increasing levels of CO2 as a stress agent. Imaging and intervention analysis will be complete in 4 years.
Results and safety
The study was stopped early (reason given: The complexity of the study and the recent slow down situation hampered the ability to recruit CAD patients therefore the study has been terminated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2021.
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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.
Terrence D Ruddy, MD principal investigator
Ottawa Heart Institute Research Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Delivery of precise levels of carbon dioxide with the RA-MR™ Virtual Sequential Gas Delivery System. and Delivery of rubidium radioisotope (Rb-82) using the automated pump/elution system in people with Coronary Artery Disease, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
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 9 inclusion and 12 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: stopped early, as of the sponsor's last update on 2 Apr 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 Canada. 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 was stopped early (reason given: The complexity of the study and the recent slow down situation hampered the ability to recruit CAD patients therefore the study has been terminated.). Results are not available in the source record.
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?
Myocardial blood flow differences (time frame: Difference between baseline rest scan blood flow and hypercapnia stress scan myocardial blood flow at 50 mmHg, 55 mmHg, 60 mmHg levels from baseline. Imaging and intervention analysis will be complete in 4 years.). 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 2 Apr 2021.