Physiological Response of Cortisol to Cardiac Catheterization

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Creighton University
Sponsor:
Information provided by (Responsible Party):
Creighton University
ClinicalTrials.gov Identifier:
NCT01822847
First received: March 28, 2013
Last updated: NA
Last verified: March 2013
History: No changes posted
  Purpose

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
Adrenal Insufficiency

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Cross-Sectional
Official Title: Physiological Response of Cortisol to Cardiac Catheterization

Resource links provided by NLM:


Further study details as provided by Creighton University:

Primary Outcome Measures:
  • cortisol change [ Time Frame: one month ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 23
Study Start Date: March 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
catheterization
patients undergoing elective heart catheterization

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.

  Eligibility

Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Both
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.

Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01822847

Contacts
Contact: Valentina Tarasova, MD 402-280-4470 ValentinaTarasova1@creighton.edu

Locations
United States, Nebraska
Creighton University Recruiting
Omaha, Nebraska, United States, 68131
Contact: Valentina Tarasova, MD    402-280-4470    ValentinaTarasova1@creighton.edu   
Sponsors and Collaborators
Creighton University
Investigators
Principal Investigator: Valentina Tarasova, MD Creighton University
  More Information

No publications provided

Responsible Party: Creighton University
ClinicalTrials.gov Identifier: NCT01822847     History of Changes
Other Study ID Numbers: 12-16583
Study First Received: March 28, 2013
Last Updated: March 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Creighton University:
adrenal
steroids
cortisol
stress

Additional relevant MeSH terms:
Adrenal Insufficiency
Adrenal Gland Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 18, 2014