CaffeineCoffee-O2NCT04585854
Effect of Caffeine on Myocardial Oxygenation
A study testing Caffeine in people with Caffeine, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Caffeine
- What is being tested?
- Caffeine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteSwitzerland
- Study dates
- 13 Nov 2020to 23 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ability to give informed consent, documented by signature
- Aged 18 to 45
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate the impact of caffeine on myocardial oxygenation and other cardiovascular magnetic resonance parameters in healthy controls.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaffeineOther
Also called Coffee
Consumption of 3 shots of espresso
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | Control population who will undergo two cardiovascular magnetic resonance exams: one at rest and one after drinking caffeine. Receives: Other: Caffeine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in myocardial oxygenation responses
Percent (%) Measure of oxygenation-sensitive signal change measured by CMR
Measured: Through study completion up to 5 hours, before and after caffeine
Secondary outcomes (8)
Difference in ejection fraction
Percent (%), measured by CMR
Measured: Through study completion up to 5 hours, before and after caffeine
Difference in cardiac index
L/min/m2, measured by CMR
Measured: 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
Measured: Through study completion up to 5 hours, before and after caffeine
Difference in myocardial time to peak strain
Milliseconds (ms), measured by CMR
Measured: 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
Measured: Through study completion up to 5 hours, before and after caffeine
Difference in myocardial parametric mapping
Milliseconds (ms), measured by CMR
Measured: Through study completion up to 5 hours, before and after caffeine
Difference in 4D blood flow
Percent, measured by CMR
Measured: Through study completion up to 5 hours, before and after caffeine
Difference in rate pressure product
Blood pressure * heart rate
Measured: Through study completion up to 5 hours, before and after caffeine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start13 Nov 2020
- Primary completion23 Oct 2021
- Study completion23 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CaffeineStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Controlled before-after comparison
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dominik P Guensch, MD, Principal investigator, Bern University Hospital, Inselspital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04585854
- Sponsor's protocol ID
- 2020-01876
- Acronym
- Coffee-O2
- Status last verified
- Oct 2021
- First submitted
- 5 Oct 2020
- Last updated
- 26 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 29730991van 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.
PubMed 30104545Kuijpers 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.
PubMed 27473274
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Caffeine on Myocardial Oxygenation
- ClinicalTrials.gov ID
- NCT04585854
- Acronym / sponsor ID
- Coffee-O2 / 2020-01876
- Conditions
- Caffeine
- Keywords
- CMR, Myocardial oxygenation, Myocardial Function, Coffee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 13 Nov 2020 (actual)
- Primary completion
- 23 Oct 2021 (actual)
- Study completion
- 23 Oct 2021 (actual)
- First posted
- 14 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Controlled before-after comparison
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Other: CaffeineControl population who will undergo two cardiovascular magnetic resonance exams: one at rest and one after drinking caffeine. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Ability to give informed consent, documented by signature
- Aged 18 to 45
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CaffeineAlso: CoffeeConsumption of 3 shots of espresso | Other | Control |
Primary outcome
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
8 secondary outcomes
Difference in ejection fraction
Time frame: Through study completion up to 5 hours, before and after caffeine
Difference in cardiac index
Time frame: Through study completion up to 5 hours, before and after caffeine
Difference in myocardial peak strain
Time frame: Through study completion up to 5 hours, before and after caffeine
Difference in myocardial time to peak strain
Time frame: Through study completion up to 5 hours, before and after caffeine
Difference in myocardial strain rate
Time frame: Through study completion up to 5 hours, before and after caffeine
Difference in myocardial parametric mapping
Time frame: Through study completion up to 5 hours, before and after caffeine
Difference in 4D blood flow
Time frame: Through study completion up to 5 hours, before and after caffeine
Difference in rate pressure product
Time frame: Through study completion up to 5 hours, before and after caffeine
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2021.
- Background: PubMed 29730991Fischer 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.
- Background: PubMed 30104545van 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.
- Background: PubMed 27473274Kuijpers 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dominik P Guensch, MD principal investigator
Bern University Hospital, Inselspital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caffeine in people with Caffeine, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in myocardial oxygenation responses (time frame: Through study completion up to 5 hours, before and after caffeine). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04585854, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2021.