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
About this trial
This is an interventional basic science trial for Physiological Changes in Deliberate Apnea
Eligibility Criteria
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
NCT ID
NCT02280226
First Posted
October 29, 2014
Last Updated
February 5, 2018
Sponsor
University Hospital, Bonn
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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