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Effect of Caffeine on Myocardial Oxygenation (Coffee-O2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04585854
Recruitment Status : Not yet recruiting
First Posted : October 14, 2020
Last Update Posted : October 14, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Brief Summary:
The purpose of this study is to investigate the impact of caffeine on myocardial oxygenation and other cardiovascular magnetic resonance parameters in healthy controls.

Condition or disease Intervention/treatment Phase
Caffeine Other: Caffeine Not Applicable

Detailed Description:
Caffeine is presumed to create a confounder with diagnostic imaging. The vasodilatory capacity is considered a key measure for the detection of significant coronary disease with stenosed epicardial arterial conduit vessels and overall microvascular function, including endothelial dysfunction. Twenty nine healthy controls will undergo a baseline cardiovascular magnetic resonance (CMR) exam. Afterwards, participants will consume coffee in the presence of study personnel. This will consist of 3 espresso shots, which will be consumed within 15 minutes. Approximately 2h after coffee consumption the CMR exam will be repeated. The goal will be to investigate the impact of caffeine on myocardial features. In particular the effect on the myocardial oxygenation response to vasodilating and vasoconstricting stimuli.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 29 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Controlled before-after comparison
Masking: None (Open Label)
Masking Description: Blinded image analysis
Primary Purpose: Other
Official Title: Effect of Caffeine on Myocardial Oxygenation
Estimated Study Start Date : December 2020
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caffeine

Arm Intervention/treatment
Control
Control population who will undergo two cardiovascular magnetic resonance exams: one at rest and one after drinking caffeine.
Other: Caffeine
Consumption of 3 shots of espresso
Other Name: Coffee




Primary Outcome Measures :
  1. Difference in myocardial oxygenation responses [ Time Frame: Through study completion up to 5 hours, before and after caffeine ]
    Percent (%) Measure of oxygenation-sensitive signal change measured by CMR


Secondary Outcome Measures :
  1. Difference in ejection fraction [ Time Frame: Through study completion up to 5 hours, before and after caffeine ]
    Percent (%), measured by CMR

  2. Difference in cardiac index [ Time Frame: Through study completion up to 5 hours, before and after caffeine ]
    L/min/m2, measured by CMR

  3. Difference in myocardial peak strain [ Time Frame: Through study completion up to 5 hours, before and after caffeine ]
    Percent (%), a measure of systolic function (shortening and thickening) of the myocardium measured by CMR

  4. Difference in myocardial time to peak strain [ Time Frame: Through study completion up to 5 hours, before and after caffeine ]
    Milliseconds (ms), measured by CMR

  5. Difference in myocardial strain rate [ Time Frame: Through study completion up to 5 hours, before and after caffeine ]
    Change in strain over time (/second), measured by CMR

  6. Difference in myocardial parametric mapping [ Time Frame: Through study completion up to 5 hours, before and after caffeine ]
    Milliseconds (ms), measured by CMR

  7. Difference in 4D blood flow [ Time Frame: Through study completion up to 5 hours, before and after caffeine ]
    Percent, measured by CMR

  8. Difference in rate pressure product [ Time Frame: Through study completion up to 5 hours, before and after caffeine ]
    Blood pressure * heart rate



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Ability to give informed consent, documented by signature
  • Aged 18 to 45

Exclusion Criteria:

  • MRI Contraindications following current institutional guidelines at the time of the CMR exam
  • Knowledge or suspicion of pregnancy (verified with a pregnancy test).
  • Consumption of caffeine 12h prior to the baseline CMR exam (outside of the study protocol).
  • Known cardiovascular disease, diabetes, severe respiratory disease, obstructive sleep apnea syndrome, chemotherapy and radiation treatment, cerebrovascular and occlusive peripheral vascular disease.

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): NCT04585854


Contacts
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Contact: Dominik P Guensch, MD +41 31 632 03 77 dominik.guensch@insel.ch
Contact: Kady Fischer, PhD +41 31 632 52 12 kady.fischer@insel.ch

Locations
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Switzerland
Bern University Hospital, Inselspital
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
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Principal Investigator: Dominik P Guensch, MD Bern University Hospital, Inselspital
Publications:
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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT04585854    
Other Study ID Numbers: 2020-01876
First Posted: October 14, 2020    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital Inselspital, Berne:
CMR
Myocardial oxygenation
Myocardial Function
Coffee
Additional relevant MeSH terms:
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Caffeine
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents