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Evaluating the Influence of Apnea on Cardiac Function Using Cardiac Magnetic Resonance Imaging.

Primary Purpose

Physiological Changes in Deliberate Apnea

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
magnetic resonance imaging (MRI)
Sponsored by
University Hospital, Bonn
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Physiological Changes in Deliberate Apnea

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Being able to hold breath deliberately at least 4,5 minutes

Exclusion Criteria:

-

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Deliberate Apnea Group

    Arm Description

    Subjects undergo maximum apnea.

    Outcomes

    Primary Outcome Measures

    Cardiac Function: Duration of Apnea
    Alteration of cardiac function in subjects undergoing maximum apnea.
    Mean Blood Flow Measurement Under Apnea Using MRI
    Blood flow pattern in subjects undergoing maximum apnea.

    Secondary Outcome Measures

    Full Information

    First Posted
    October 29, 2014
    Last Updated
    February 5, 2018
    Sponsor
    University Hospital, Bonn
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02280226
    Brief Title
    Evaluating the Influence of Apnea on Cardiac Function Using Cardiac Magnetic Resonance Imaging.
    Official Title
    Evaluating the Influence of Apnea on Heart Function With Strain Analysis and Measurement of Fibrosis Derived From T1-mapping Using Cardiac Magnetic Resonance Imaging (MRI).
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2014 (undefined)
    Primary Completion Date
    July 2016 (Actual)
    Study Completion Date
    July 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University Hospital, Bonn

    4. Oversight

    5. Study Description

    Brief Summary
    Former studies revealed a distinct pattern of changes in circulation during deliberate apnea. Blood pressure rises significantly often accompanied by bradycardia. Further studies confirmed a massive increase of total vascular resistance as it also happens in shock to maintain perfusion of heart, lung and brain. This study is to determine the exact alterations of the cardiac function during this reaction, show the redistribution of blood volume in apnea and evaluate possible longterm effects on the central nervous system caused by repeated apnea via magnetic resonance imaging.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Physiological Changes in Deliberate Apnea

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    17 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Deliberate Apnea Group
    Arm Type
    Experimental
    Arm Description
    Subjects undergo maximum apnea.
    Intervention Type
    Device
    Intervention Name(s)
    magnetic resonance imaging (MRI)
    Primary Outcome Measure Information:
    Title
    Cardiac Function: Duration of Apnea
    Description
    Alteration of cardiac function in subjects undergoing maximum apnea.
    Time Frame
    every minute under apnea (from 0 up to 9 minutes and rest) depending on personal best with a mean of 5 measurements
    Title
    Mean Blood Flow Measurement Under Apnea Using MRI
    Description
    Blood flow pattern in subjects undergoing maximum apnea.
    Time Frame
    Every minute under apnea (from 0 up to 9 minutes and rest) depending on personal best with a mean of 5 measurements

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Being able to hold breath deliberately at least 4,5 minutes Exclusion Criteria: -

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    29909774
    Citation
    Eichhorn L, Doerner J, Luetkens JA, Lunkenheimer JM, Dolscheid-Pommerich RC, Erdfelder F, Fimmers R, Nadal J, Stoffel-Wagner B, Schild HH, Hoeft A, Zur B, Naehle CP. Cardiovascular magnetic resonance assessment of acute cardiovascular effects of voluntary apnoea in elite divers. J Cardiovasc Magn Reson. 2018 Jun 18;20(1):40. doi: 10.1186/s12968-018-0455-x.
    Results Reference
    derived

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    Evaluating the Influence of Apnea on Cardiac Function Using Cardiac Magnetic Resonance Imaging.

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