Clinical trial NCT04585854: Effect of Caffeine on Myocardial Oxygenation
Official title: Effect of Caffeine on Myocardial Oxygenation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caffeine
Keywords: CMR
Myocardial oxygenation
Myocardial Function
Coffee
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2020-10-14
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Controlled before-after comparison
Primary purpose: OTHER

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.

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.

Eligibility 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.

Primary outcomes:
measure: Difference in myocardial oxygenation responses
timeFrame: Through study completion up to 5 hours, before and after caffeine
Secondary outcomes:
measure: Difference in ejection fraction
timeFrame: Through study completion up to 5 hours, before and after caffeine
measure: Difference in cardiac index
timeFrame: Through study completion up to 5 hours, before and after caffeine
measure: Difference in myocardial peak strain
timeFrame: Through study completion up to 5 hours, before and after caffeine
measure: Difference in myocardial time to peak strain
timeFrame: Through study completion up to 5 hours, before and after caffeine
measure: Difference in myocardial strain rate
timeFrame: Through study completion up to 5 hours, before and after caffeine
measure: Difference in myocardial parametric mapping
timeFrame: Through study completion up to 5 hours, before and after caffeine
measure: Difference in 4D blood flow
timeFrame: Through study completion up to 5 hours, before and after caffeine
measure: Difference in rate pressure product
timeFrame: Through study completion up to 5 hours, before and after caffeine
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Bern University Hospital, Inselspital
Study officials:
affiliation: Bern University Hospital, Inselspital
name: Dominik P Guensch, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fischer K, Yamaji K, Luescher S, Ueki Y, Jung B, von Tengg-Kobligk H, Windecker S, Friedrich MG, Eberle B, Guensch DP. Feasibility of cardiovascular magnetic resonance to detect oxygenation deficits in patients with multi-vessel coronary artery disease triggered by breathing maneuvers. J Cardiovasc Magn Reson. 2018 May 7;20(1):31. doi: 10.1186/s12968-018-0446-y.
citation: van Dijk R, Ties D, Kuijpers D, van der Harst P, Oudkerk M. Effects of Caffeine on Myocardial Blood Flow: A Systematic Review. Nutrients. 2018 Aug 13;10(8):1083. doi: 10.3390/nu10081083.
citation: Kuijpers D, Prakken NH, Vliegenthart R, van Dijkman PR, van der Harst P, Oudkerk M. Caffeine intake inverts the effect of adenosine on myocardial perfusion during stress as measured by T1 mapping. Int J Cardiovasc Imaging. 2016 Oct;32(10):1545-53. doi: 10.1007/s10554-016-0949-2. Epub 2016 Jul 29.