NCT04585854

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 14, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

November 13, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 23, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 23, 2021

Completed
Last Updated

October 26, 2021

Status Verified

October 1, 2021

Enrollment Period

11 months

First QC Date

October 5, 2020

Last Update Submit

October 25, 2021

Conditions

Caffeine

Keywords

CMRMyocardial oxygenationMyocardial FunctionCoffee

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • 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

  • +3 more secondary outcomes

Study Arms (1)

Control

OTHER

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

Other: Caffeine

Interventions

CaffeineOTHER

Consumption of 3 shots of espresso

Also known as: Coffee
Control

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Ability to give informed consent, documented by signature
  • Aged 18 to 45

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bern University Hospital, Inselspital

Bern, 3010, Switzerland

Location

Related Publications (3)

  • 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.

    PMID: 29730991BACKGROUND

  • 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.

    PMID: 30104545BACKGROUND

  • 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.

    PMID: 27473274BACKGROUND

MeSH Terms

Interventions

CaffeineCoffee

Intervention Hierarchy (Ancestors)

XanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingPlant PreparationsBiological ProductsComplex MixturesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Dominik P Guensch, MD

    Bern University Hospital, Inselspital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Blinded image analysis
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Controlled before-after comparison
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2020

First Posted

October 14, 2020

Study Start

November 13, 2020

Primary Completion

October 23, 2021

Study Completion

October 23, 2021

Last Updated

October 26, 2021

Record last verified: 2021-10

Locations

CH(1)