CO2 as a Stress Agent for Perfusion Imaging

NCT ID: NCT02043535

Last Updated: 2021-04-02

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

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-12

Study Completion Date

2020-10-15

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Delivery of precise levels of carbon dioxide with the RA-MR™ Virtual Sequential Gas Delivery System.

Intervention Type DEVICE

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

Intervention Type DEVICE

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

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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

Intervention Type DEVICE

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.

Intervention Type DEVICE

Other Intervention Names

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the RA-MR™ System Ruby-Fill™

Eligibility Criteria

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Inclusion Criteria

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
* Stable coronary artery disease on a stable medication regime.
* Healthy volunteers without known heart disease
* Low risk of coronary artery disease (CAD)

Exclusion Criteria

* 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
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ottawa Heart Institute Research Corporation

OTHER

Sponsor Role lead

Responsible Party

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Terrence Ruddy

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Terrence D Ruddy, MD

Role: PRINCIPAL_INVESTIGATOR

Ottawa Heart Institute Research Corporation

Locations

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University Of Ottawa Heart Institute

Ottawa, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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20140012

Identifier Type: -

Identifier Source: org_study_id

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