Physiological Response of Cortisol to Cardiac Catheterization

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. Identifier: NCT01822847
Recruitment Status : Completed
First Posted : April 2, 2013
Last Update Posted : February 26, 2015
Information provided by (Responsible Party):
Creighton University

Brief Summary:
Cortisol is essential for survival. The importance of cortisol response is most apparent in patients with partial or complete deficiency of glucocorticoids during stressful events such as illness or surgery.

Condition or disease
Adrenal Insufficiency

Detailed Description:
It is known that cortisol and other stress hormones increase during acute myocardial infarction as well (9-11). Cardiac catheterization is an essential tool for the management of acute coronary syndrome, and for the evaluation of the burden of coronary artery disease in cardiac patients.

Study Type : Observational
Actual Enrollment : 24 participants
Observational Model: Case-Crossover
Time Perspective: Cross-Sectional
Official Title: Physiological Response of Cortisol to Cardiac Catheterization
Study Start Date : March 2013
Primary Completion Date : April 2014
Study Completion Date : April 2014

patients undergoing elective heart catheterization

Primary Outcome Measures :
  1. cortisol change [ Time Frame: one month ]
    On the day of the procedure a total of 4 venous blood samples for random plasma cortisol level will be obtained. Blood will be drawn at 5 minutes prior to the procedure, at 30 minutes and 60 minutes during the cardiac catheterization. Another sample will be drawn in 3 hours after cardiac catheterization prior to the patients discharge. a cortisol level will be drawn at a "nonstressful" visit

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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
30 males and females, age 20-90 years who are scheduled for elective cardiac catheterization procedure.

Inclusion Criteria:

  • Patients undergoing elective cardiac catheterization, who are willing and able to give consent.

Exclusion Criteria:

  • • Patients with .primary or secondary adrenal insufficiency.

    • Patients taking steroids in the doses equivalent of at least 5 mg of prednisone daily for more than 3 weeks in the previous year.
    • Patients undergoing cardiac catheterization in the setting of acute coronary syndrome, eg. STEMI, NSTEMI and unstable angina.
    • Patients with low albumin level (<3.5 g/dL)

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 identifier (NCT number): NCT01822847

United States, Nebraska
Creighton University
Omaha, Nebraska, United States, 68131
Sponsors and Collaborators
Creighton University
Principal Investigator: Valentina Tarasova, MD Creighton University

Responsible Party: Creighton University Identifier: NCT01822847     History of Changes
Other Study ID Numbers: 12-16583
First Posted: April 2, 2013    Key Record Dates
Last Update Posted: February 26, 2015
Last Verified: February 2015

Keywords provided by Creighton University:

Additional relevant MeSH terms:
Adrenal Insufficiency
Adrenal Gland Diseases
Endocrine System Diseases
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Cortisol succinate
Anti-Inflammatory Agents