Effect of Caffeine on Myocardial Oxygenation

Not Applicable

Completed

• Conditions: Caffeine
• Interventions: Other: Caffeine

• Registration Number: NCT04585854
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

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.

Study Timeline

• Study First Submitted: 2020-10-05
• Study First Submitted QC: 2020-10-12
• Study First Posted: 2020-10-14
• Study Start: 2020-11-13
• Status Verified: 2021-10
• Primary Completion: 2021-10-23
• Study Completion: 2021-10-23
• Last Update Submitted: 2021-10-25
• Last Update Posted: 2021-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Control	Caffeine	Control population who will undergo two cardiovascular magnetic resonance exams: one at rest and one after drinking caffeine.

Primary Outcome Measures

Name	Time	Method
Difference in myocardial oxygenation responses	Through study completion up to 5 hours, before and after caffeine	Percent (%) Measure of oxygenation-sensitive signal change measured by CMR

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Bern University Hospital, Inselspital; 🇨🇭 Bern, Switzerland