NCT00693758

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jan 2006

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

December 10, 2007

Completed
6 months until next milestone

First Posted

Study publicly available on registry

June 9, 2008

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

October 4, 2011

Status Verified

October 1, 2011

Enrollment Period

5.7 years

First QC Date

December 10, 2007

Last Update Submit

October 2, 2011

Conditions

Vascular DiseasesMyocardial Ischemia

Keywords

MRIcoronary reactivitycoronary physiology

Outcome Measures

Primary Outcomes (1)

  • BOLD-MRI signal intensity changes

    60

Secondary Outcomes (1)

  • Flow changes

    60 min

Study Arms (7)

1

NO INTERVENTION

healthy volunteers without intervention

Device: Breathing gas

2

NO INTERVENTION

patients with suspected coronary artery disease without intervention

3

EXPERIMENTAL

Healthy volunteers during adenosine infusion

Drug: adenosineDevice: Blood pressure cuff

4

EXPERIMENTAL

Healthy volunteers during changes of breathing gases (CO2, O2)

Other: modified end-tidal forcing system

5

EXPERIMENTAL

patients with suspected coronary artery disease during adenosine infusion

Drug: adenosine

6

EXPERIMENTAL

patients with suspected coronary artery disease during changes of breathing gases

Other: modified end-tidal forcing system

7

EXPERIMENTAL

Assessment of reactive hyperemia in arms of healthy volunteers to improve sequences

Other: arm cuff occlusion

Interventions

adenosineDRUG

intravenous infusion of adenosine (140microgr./min/kg)

Also known as: Adenosine stress
35
modified end-tidal forcing systemOTHER

changes in partial pressures of O2 and CO2 in inspired air

Also known as: O2 / CO2 changes in inspired air
46
arm cuff occlusionOTHER

3 min. lasting upper arm cuff occlusion

7
Breathing gasDEVICE

Changes in pO2 and pCO2 in inspired air mix

1
Blood pressure cuffDEVICE

supra-systolic arm occlusion with pressure cuff

3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stephenson CMR Centre at Foothills Medical Centre, University of Calgary

Calgary, Alberta, T2N 2T9, Canada

Location

MeSH Terms

Conditions

Vascular DiseasesMyocardial Ischemia

Interventions

Adenosine

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesHeart Diseases

Intervention Hierarchy (Ancestors)

Purine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Study Officials

  • Matthias Friedrich, MD

    University of Calgary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adunct Research Associate Professor

Study Record Dates

First Submitted

December 10, 2007

First Posted

June 9, 2008

Study Start

January 1, 2006

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

October 4, 2011

Record last verified: 2011-10

Locations

CA(1)