Effect of Caffeine on Myocardial Oxygenation (Coffee-O2)

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

Study Overview

• Status: Completed
• Conditions: Caffeine
• Intervention / Treatment: Other: Caffeine

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.

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Bern University Hospital, Inselspital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 41 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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 Names: Coffee

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in ejection fraction	Percent (%), measured by CMR	Through study completion up to 5 hours, before and after caffeine
Difference in cardiac index	L/min/m2, measured by CMR	Through study completion up to 5 hours, before and after caffeine
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
Difference in myocardial time to peak strain	Milliseconds (ms), measured by CMR	Through study completion up to 5 hours, before and after caffeine
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
Difference in myocardial parametric mapping	Milliseconds (ms), measured by CMR	Through study completion up to 5 hours, before and after caffeine
Difference in 4D blood flow	Percent, measured by CMR	Through study completion up to 5 hours, before and after caffeine
Difference in rate pressure product	Blood pressure * heart rate	Through study completion up to 5 hours, before and after caffeine

Collaborators and Investigators

• Sponsor: University Hospital Inselspital, Berne

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2020
• Primary Completion (Actual): October 23, 2021
• Study Completion (Actual): October 23, 2021

Study Registration Dates

• First Submitted: October 5, 2020
• First Submitted That Met QC Criteria: October 12, 2020
• First Posted (Actual): October 14, 2020

Study Record Updates

• Last Update Posted (Actual): October 26, 2021
• Last Update Submitted That Met QC Criteria: October 25, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: CMR; Coffee; Myocardial Function; Myocardial oxygenation
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Purinergic Antagonists; Purinergic Agents; Phosphodiesterase Inhibitors; Purinergic P1 Receptor Antagonists; Central Nervous System Stimulants; Caffeine
• Other Study ID Numbers: 2020-01876

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No