Effect of Caffeine on Myocardial Oxygenation

Caffeine Clinical Trial

— Coffee-O2  

Official title:

Effect of Caffeine on Myocardial Oxygenation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04585854
• Other study ID #: 2020-01876
• Status: Completed
• Phase: N/A
• Start date: November 13, 2020
• Est. completion date: October 23, 2021

Study information

• Verified date: October 2021
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: October 23, 2021
• Est. primary completion date: October 23, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Caffeine

Intervention

Other:
• Caffeine
Consumption of 3 shots of espresso

Locations

Country	Name	City	State
Switzerland	Bern University Hospital, Inselspital	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

References & Publications (3)

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. — View 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. — View 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). pii: E1083. doi: 10.3390/nu10081083. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in myocardial oxygenation responses	Percent (%) Measure of oxygenation-sensitive signal change measured by CMR	Through study completion up to 5 hours, before and after caffeine
Secondary	Difference in ejection fraction	Percent (%), measured by CMR	Through study completion up to 5 hours, before and after caffeine
Secondary	Difference in cardiac index	L/min/m2, measured by CMR	Through study completion up to 5 hours, before and after caffeine
Secondary	Difference in myocardial peak strain	Percent (%), a measure of systolic function (shortening and thickening) of the myocardium measured by CMR	Through study completion up to 5 hours, before and after caffeine
Secondary	Difference in myocardial time to peak strain	Milliseconds (ms), measured by CMR	Through study completion up to 5 hours, before and after caffeine
Secondary	Difference in myocardial strain rate	Change in strain over time (/second), measured by CMR	Through study completion up to 5 hours, before and after caffeine
Secondary	Difference in myocardial parametric mapping	Milliseconds (ms), measured by CMR	Through study completion up to 5 hours, before and after caffeine
Secondary	Difference in 4D blood flow	Percent, measured by CMR	Through study completion up to 5 hours, before and after caffeine
Secondary	Difference in rate pressure product	Blood pressure * heart rate	Through study completion up to 5 hours, before and after caffeine