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Completed

NCT Number: NCT02079454

Post-operative Cardiac Outcome of Non-cardiac Surgery Predicted by INVOS

Research aimed to find a correlation with an invos drop and cardiac events in the peri-operative period of non cardiac surgery.

The investigators postulate that a drop in the Invos numbers (with or without significant drop in BP) is associated with a variable degree of cardiac suffering.

The idea is to prevent per and foremostpost-operative myocardial necrosis complications by acting as soon as we have an INVOS drop during anesthesia.

The "cardiac events" will be monitored and defined according to the EHA (european heart association) guidelines.

(Changes of the EKG and/or troponin I values above the threshold). Patient will be monitored per and post operatively.

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Key information

Conditions

Invos Cardiac Outcome Peri-operative

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

cliniques universitaires St Luc

Brussels, Brabant, 1200, Belgium

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male and female
  • Age minimum 18 years old

Exclusion criteria

  • Chronic renal failure

Treatment and study plan

Primary outcomes

  1. A composite measurement of major vascular events in the post-operative period

    Time frame: 96 hours post-operative

    Myocardial infarction (measured by positivation of troponin I assay above the defined threshold) associated with clinical data (pain, dyspnea,...) or ST modification on the EKG or apparition of a new LBBB, or new wall abnormalities on the TTE.

    Or new TIAs or CVAs

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Registry information

Official study title

Valeur Predictive de l'INVOS Sur l'Outcome Cardiaque en Post-opératoire. (French Title)

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Mar 5, 2014
Registry last updated
Mar 5, 2014

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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