Effect of Caffeine on Myocardial Oxygenation

Effect of Caffeine on Myocardial Oxygenation

Sponsors

Lead Sponsor: University Hospital Inselspital, Berne

Source 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.

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.

Overall Status Not yet recruiting
Start Date December 2020
Completion Date August 2022
Primary Completion Date August 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Difference in myocardial oxygenation responses Through study completion up to 5 hours, before and after caffeine
Secondary Outcome
Measure Time Frame
Difference in ejection fraction Through study completion up to 5 hours, before and after caffeine
Difference in cardiac index Through study completion up to 5 hours, before and after caffeine
Difference in myocardial peak strain Through study completion up to 5 hours, before and after caffeine
Difference in myocardial time to peak strain Through study completion up to 5 hours, before and after caffeine
Difference in myocardial strain rate Through study completion up to 5 hours, before and after caffeine
Difference in myocardial parametric mapping Through study completion up to 5 hours, before and after caffeine
Difference in 4D blood flow Through study completion up to 5 hours, before and after caffeine
Difference in rate pressure product Through study completion up to 5 hours, before and after caffeine
Enrollment 29
Condition
Intervention

Intervention Type: Other

Intervention Name: Caffeine

Description: Consumption of 3 shots of espresso

Arm Group Label: Control

Other Name: Coffee

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: 45 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Dominik P Guensch, MD Principal Investigator Bern University Hospital, Inselspital
Overall Contact

Last Name: Dominik P Guensch, MD

Phone: +41 31 632 03 77

Email: [email protected]

Location
Facility: Bern University Hospital, Inselspital
Location Countries

Switzerland

Verification Date

October 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Number Of Arms 1
Arm Group

Label: Control

Type: Other

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

Acronym Coffee-O2
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Intervention Model Description: Controlled before-after comparison

Primary Purpose: Other

Masking: None (Open Label)

Masking Description: Blinded image analysis

Source: ClinicalTrials.gov