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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Oliver Strohm, University of Calgary
ClinicalTrials.gov Identifier:
NCT00693758
First received: December 10, 2007
Last updated: October 2, 2011
Last verified: October 2011
History of Changes
  Purpose

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 Intervention Phase
Vascular Diseases
Myocardial Ischemia
 Drug: adenosine
Other: modified end-tidal forcing system
Other: arm cuff occlusion
Device: Breathing gas
Device: Blood pressure cuff
 Phase 0

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Magnetic Resonance Imaging for the Detection of Oxygen Changes in the Heart

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • BOLD-MRI signal intensity changes [ Time Frame: 60 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Flow changes [ Time Frame: 60 min ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: January 2006
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Arm cuff occlusion

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Oliver Strohm, Adunct Research Associate Professor, University of Calgary
ClinicalTrials.gov Identifier: NCT00693758     History of Changes
Other Study ID Numbers: 18798, 18798
Study First Received: December 10, 2007
Last Updated: October 2, 2011
Health Authority: Canada: Health Canada

Keywords provided by University of Calgary:
MRI
coronary reactivity
coronary physiology

Additional relevant MeSH terms:
Myocardial Ischemia
Coronary Artery Disease
Ischemia
Vascular Diseases
Heart Diseases
Cardiovascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Pathologic Processes
Adenosine
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on May 23, 2013