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Assessment of Oxygen Changes in the Heart With Cardio-vascular Magnetic Resonance Imaging

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ClinicalTrials.gov Identifier: NCT00693758
Recruitment Status : Completed
First Posted : June 9, 2008
Last Update Posted : October 4, 2011
Sponsor:
Information provided by (Responsible Party):
Oliver Strohm, University of Calgary

Brief Summary:
The ability of a new SSFP-based BOLD MRI sequence to assess myocardial oxygenation changes in response to coronary flow changes induced by adenosine and increased CO2-partial pressure will be examined in healthy volunteers and patients with suspected coronary artery disease. Also the susceptibility of a new SSFP-based BOLD sensitive MRI sequence to changes in arterial oxygenation will be examined. This will help understand the physiologic basis of oxygen sensitive imaging of the heart.

Condition or disease Intervention/treatment Phase
Vascular Diseases Myocardial Ischemia Drug: adenosine Other: modified end-tidal forcing system Other: arm cuff occlusion Device: Breathing gas Device: Blood pressure cuff Early Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Magnetic Resonance Imaging for the Detection of Oxygen Changes in the Heart
Study Start Date : January 2006
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Adenosine
U.S. FDA Resources

Arm Intervention/treatment
No Intervention: 1
healthy volunteers without intervention
Device: Breathing gas
Changes in pO2 and pCO2 in inspired air mix
No Intervention: 2
patients with suspected coronary artery disease without intervention
Experimental: 3
Healthy volunteers during adenosine infusion
Drug: adenosine
intravenous infusion of adenosine (140microgr./min/kg)
Other Name: Adenosine stress
Device: Blood pressure cuff
supra-systolic arm occlusion with pressure cuff
Experimental: 4
Healthy volunteers during changes of breathing gases (CO2, O2)
Other: modified end-tidal forcing system
changes in partial pressures of O2 and CO2 in inspired air
Other Name: O2 / CO2 changes in inspired air
Experimental: 5
patients with suspected coronary artery disease during adenosine infusion
Drug: adenosine
intravenous infusion of adenosine (140microgr./min/kg)
Other Name: Adenosine stress
Experimental: 6
patients with suspected coronary artery disease during changes of breathing gases
Other: modified end-tidal forcing system
changes in partial pressures of O2 and CO2 in inspired air
Other Name: O2 / CO2 changes in inspired air
Experimental: 7
Assessment of reactive hyperemia in arms of healthy volunteers to improve sequences
Other: arm cuff occlusion
3 min. lasting upper arm cuff occlusion



Primary Outcome Measures :
  1. BOLD-MRI signal intensity changes [ Time Frame: 60 ]

Secondary Outcome Measures :
  1. Flow changes [ Time Frame: 60 min ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Informed written consent
  • age > 18 years
  • no known cardiovascular disease and no vasoactive medication (if recruited as healthy volunteer)
  • suspected coronary artery disease or microvascular dysfunction (if recruited as patient)
  • no known obstructive or restrictive lung disease
  • fasting for 4 hours prior to the study

Exclusion Criteria:

  • Contraindications for MRI
  • Known obstructive or restrictive lung disease
  • concomitant serious medical condition

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00693758


Locations
Canada, Alberta
Stephenson CMR Centre at Foothills Medical Centre, University of Calgary
Calgary, Alberta, Canada, T2N 2T9
Sponsors and Collaborators
University of Calgary
Investigators
Principal Investigator: Matthias Friedrich, MD University of Calgary

Responsible Party: Oliver Strohm, Adunct Research Associate Professor, University of Calgary
ClinicalTrials.gov Identifier: NCT00693758     History of Changes
Other Study ID Numbers: 18798
18798
First Posted: June 9, 2008    Key Record Dates
Last Update Posted: October 4, 2011
Last Verified: October 2011

Keywords provided by Oliver Strohm, University of Calgary:
MRI
coronary reactivity
coronary physiology

Additional relevant MeSH terms:
Ischemia
Vascular Diseases
Myocardial Ischemia
Coronary Artery Disease
Pathologic Processes
Cardiovascular Diseases
Heart Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Adenosine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Vasodilator Agents
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action