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Digital Image Correlation in Right Ventricular Evaluation (CardiomeDIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03115294
Recruitment Status : Active, not recruiting
First Posted : April 14, 2017
Last Update Posted : September 25, 2019
Sponsor:
Collaborator:
Tampere University of Technology
Information provided by (Responsible Party):
Jari Laurikka, Tampere University Hospital

Brief Summary:
Observational study of patients undergoing open heart surgery. During the procedure video clips of right heart are stored and compared to trans-oesophageal ultrasound recordings and ECG recordings.

Condition or disease Intervention/treatment Phase
Heart Ventricles Drug: Theophylline Procedure: Ventilator positive end expiratory pressure adjustment Device: Videorecording Not Applicable

Detailed Description:
Observational study of patients undergoing open heart surgery. During the procedure video clips of right heart are stored and compared to trans-oesophageal ultrasound recordings and ECG recordings. Right heart volume status and function is controlled and induced with theophylline and ventilator regulated positive end-expiratory pressure recordings.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Patients undergo medication intervention (w/intravenous theophylline) and ventilator volume adjustements, and serial ventricular function parameters are compared (pre-and post-intervention measurements).
Masking: None (Open Label)
Masking Description: video analysts do not get information of the clinical data or procedure phase
Primary Purpose: Device Feasibility
Official Title: Digital Image Correlation in Right Ventricular Evaluation in Cardiac Surgery
Actual Study Start Date : May 16, 2016
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Study group
Patients undergo procedure with stepwise measurements and ventilator + volume adjustment + iv theophylline Myocardial movement recording using videoscanning
Drug: Theophylline
iv injection

Procedure: Ventilator positive end expiratory pressure adjustment
Positive end-expiratory pressure variation

Device: Videorecording
Myocardial movement videorecording




Primary Outcome Measures :
  1. Heart ventricle function [ Time Frame: Within the operation ]
    Changes in heart ventricle contraction status


Other Outcome Measures:
  1. ECG [ Time Frame: Within the operation ]
    Simultaneous ECG recording and analysis during outcome 4 measurements

  2. Transesophageal ultrasound [ Time Frame: Within the operation ]
    Myocardial contraction range during video-clip

  3. Cardiac output [ Time Frame: Within the operation ]
    Measurement of cardiac output



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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • open heart surgery, patient acceptance and informed consent, age 75 or more

Exclusion Criteria:

  • patient refusal, psychiatric disorder or intoxication, irrepairable coronary artery disease, epilepsy or active neurological condition, active tbc or other contagious infection.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03115294


Locations
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Finland
Tampere University Hospital, Heart Center
Tampere, Finland, 33521
Sponsors and Collaborators
Tampere University Hospital
Tampere University of Technology
Investigators
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Principal Investigator: Jari Laurikka, MD,PhD Professor, Cardio-thoracic Surgery
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Responsible Party: Jari Laurikka, Professor, Tampere University Hospital
ClinicalTrials.gov Identifier: NCT03115294    
Other Study ID Numbers: R16045
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: non-identifiable data to Tampere University of Technology research group

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Theophylline
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents