Impact of Breathing Maneuvers on the Oxygenation Supply of the Heart Assessed With MRI in Patients With Coronary Artery Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 8 January 2018
• Main ID: NCT02233634
• Date of registration: 03/09/2014
• Prospective Registration: Yes
• Primary sponsor: University Hospital Inselspital, Berne
• Public title: Impact of Breathing Maneuvers on the Oxygenation Supply of the Heart Assessed With MRI in Patients With Coronary Artery Disease CADOS-CMR
• Scientific title: Impact of Breathing Maneuvers and Oxygen Administration on Myocardial Oxygenation in Patients With Coronary Artery Disease Compared With Healthy Controls - Non-invasive Assessment With Oxygenation-sensitive Cardiovascular Magnetic Resonance Imaging (OS-CMR)
• Date of first enrolment: October 1, 2014
• Target sample size: 36
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02233634
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Factorial Assignment. Primary purpose: Supportive Care. Masking: Single (Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Switzerland

Contacts

• Name: Balthasar Eberle, MD
• Affiliation: Department of Anaesthesiology and Pain Therapy, Bern University Hospital, Inselspital, Bern

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients with known relevant coronary artery stenosis (defined by previous coronary
angiography, QCA: reduction in lumen-diameter of the vessel >50%) with a scheduled
intervention or operation to treat this stenosis (staged PCI or coronary artery bypass
surgery)

- CMR feasible prior to intervention or surgery

- Age =18 years

- Written informed consent

- For healthy participants: Absence of cardiovascular and lung disease, and absence of
medication with cardiovascular effects

- Absence of exclusion criteria

Exclusion Criteria

- General Contraindication against MRI-Scans: (claustrophobia, ferromagnetic implants,
clips, pacemakers, shrapnels, ophthalmic metal deposits)

- Pregnancy or inconclusive test result

- Age <18 years

- Inability to give informed consent

- Consumption of caffeine, tea, treatment of dipyridamol <12h before the scan

- Medication with calcium antagonists (ok, if can be paused on the day of the scan)

- Constant medication with nitrates (ok, if can be paused on the day of the scan)

- Medication with methyl-xanthines

- Acute myocardial ischemia/myocardial infarction

- Previous Coronary Bypass Surgery

- Pulmonary Disease

- Enrolment of the investigator, his/her family members, employees and other dependent
persons

- Presence of cardiac or lung disease for healthy volunteers, nicotine consumption
within the last 6 months



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Coronary Artery Disease

Intervention(s)

Drug: Oxygen

Other: Hyperventilation Breath-hold (HVBH)

Other: HVBH with Oxygen

Primary Outcome(s)

Change of signal intensity (SI) in oxygenation-sensitive (OS) Cardiovascular Magnetic Resonance (CMR) during the breathing maneuvers/oxygen administration [Time Frame: During CMR scan, expected to be on average approx. 45 minutes]

Secondary Outcome(s)

Comparison of OS-SI changes between healthy and post-stenotic myocardium during the breathing-maneuvers/oxygen administration in CAD patients [Time Frame: During CMR scan, expected to be on average approx. 45 minutes]

Comparison of OS-SI changes between healthy volunteers and and CAD patients during the breathing-maneuvers/oxygen administration [Time Frame: During CMR scan, expected to be on average approx. 45 minutes]

Comparison between OS-SI changes during the breathing maneuvers/oxygen administration and results in quantitative coronary angiography in CAD patients (reduction of lumen diameter) [Time Frame: During CMR scan, expected to be on average approx. 45 minutes, and the subsequent coronary angiography]

Secondary ID(s)

107/14

GUDD 1-14

Source(s) of Monetary Support

Please refer to primary and secondary sponsors