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Vascular Function on the First Day After Cardiac Surgery

Sponsor
Norwegian University of Science and Technology (Other)
Overall Status
Completed
CT.gov ID
NCT02001090
Collaborator
St. Olavs Hospital (Other)
25
Enrollment
1
Location
4.9
Actual Duration (Months)
5.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study examines the flow mediated dilation (FMD) of the brachial artery before and after cardiac surgery. FMD is measured with ultrasound technique. Increased flow is achieved trough obstructing blood flow with a cuff around the forearm for five minutes. FMD is measured before surgery and on the first morning after the operation.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    25 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Vascular Function on the First Day After Cardiac Surgery
    Actual Study Start Date :
    Dec 1, 2013
    Actual Primary Completion Date :
    Apr 29, 2014
    Actual Study Completion Date :
    Apr 29, 2014

    Arms and Interventions

    Arm Intervention/Treatment
    CABG patients

    Patients undergoing cardiac surgery for coronary artery disease with the use of heart-lung machine in St Olavs Hospital Trondheim University Hospital.

    Outcome Measures

    Primary Outcome Measures

    1. flow mediated dilation of the brachial artery [one day]

      Transitory change in FMD as a consequence of cardiac surgery with use of extra corporal circulation.

    Secondary Outcome Measures

    1. Reactive hyperemia [one day]

      Transitory change in reactive hyperemia after five minutes of occlusion of forearm blood flow as a consequence of cardiac surgery with the use of extra corporal circulation.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • admitted for coronary artery bypass surgery
    Exclusion Criteria:

    • Ongoing treatment with nitrates or RAAS inhibiting drugs

    • unstable coronary syndrome

    • unstable circulation/shock

    • renal failure

    • hepatic failure

    • autoimmune or inflammatory disease

    • untreated hypertension.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 St. Olavs Hospital Trondheim Sør Trøndelag Norway 7006

    Sponsors and Collaborators

    • Norwegian University of Science and Technology
    • St. Olavs Hospital

    Investigators

    • Study Director: Idar Kirkeby-Garstad, Md. PhD., Department of Cardiothoracic Anesthesiolgy and Intensive Care, St. Olav's Hospital, Trondheim, Norway

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Norwegian University of Science and Technology
    ClinicalTrials.gov Identifier:
    NCT02001090
    Other Study ID Numbers:
    • REK nr 2013/1758
    First Posted:
    Dec 4, 2013
    Last Update Posted:
    Sep 19, 2017
    Last Verified:
    Sep 1, 2017
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Norwegian University of Science and Technology
    Cardiac Surgical Procedures
    Heart-Lung Machine
    Coronary Artery Bypass
    Brachial Artery
    Vasodilation
    Regional Blood Flow
    Ultrasonography
    Additional relevant MeSH terms:
    Coronary Artery Disease

    Study Results

    No Results Posted as of Sep 19, 2017