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Completed

NCT Number: NCT04585854

Effect of Caffeine on Myocardial Oxygenation

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

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bern University Hospital, Inselspital

Bern, 3010, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Caffeine

Other

Consumption of 3 shots of espresso

Other names: Coffee

Primary outcomes

  1. Difference in myocardial oxygenation responses

    Time frame: Through study completion up to 5 hours, before and after caffeine

    Percent (%) Measure of oxygenation-sensitive signal change measured by CMR

Secondary outcomes

  1. Difference in ejection fraction

    Time frame: Through study completion up to 5 hours, before and after caffeine

    Percent (%), measured by CMR

  2. Difference in cardiac index

    Time frame: Through study completion up to 5 hours, before and after caffeine

    L/min/m2, measured by CMR

  3. Difference in myocardial peak strain

    Time frame: 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

  4. Difference in myocardial time to peak strain

    Time frame: Through study completion up to 5 hours, before and after caffeine

    Milliseconds (ms), measured by CMR

  5. Difference in myocardial strain rate

    Time frame: Through study completion up to 5 hours, before and after caffeine

    Change in strain over time (/second), measured by CMR

  6. Difference in myocardial parametric mapping

    Time frame: Through study completion up to 5 hours, before and after caffeine

    Milliseconds (ms), measured by CMR

  7. Difference in 4D blood flow

    Time frame: Through study completion up to 5 hours, before and after caffeine

    Percent, measured by CMR

  8. Difference in rate pressure product

    Time frame: Through study completion up to 5 hours, before and after caffeine

    Blood pressure * heart rate

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Acronym: Coffee-O2

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 14, 2020
Registry last updated
Oct 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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