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Completed

NCT Number: NCT03115294

Digital Image Correlation in Right Ventricular Evaluation

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.

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Key information

Conditions

Heart Ventricles

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tampere University Hospital, Heart Center

Tampere, 33521, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Theophylline

Drug

iv injection

Ventilator positive end expiratory pressure adjustment

Procedure

Positive end-expiratory pressure variation

Videorecording

Device

Myocardial movement videorecording

Primary outcomes

  1. Heart ventricle function

    Time frame: Within the operation

    Changes in heart ventricle contraction status

Other outcomes

  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

Sponsors and collaborators

Lead sponsor

Tampere University Hospital

Other

Collaborators

  • Tampere University of Technology

Registry information

Official study title

Digital Image Correlation in Right Ventricular Evaluation in Cardiac Surgery

Acronym: CardiomeDIC

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Apr 14, 2017
Registry last updated
Dec 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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