Physiological Response of Cortisol to Cardiac Catheterization

Adrenal Insufficiency Clinical Trial

Official title:

Physiological Response of Cortisol to Cardiac Catheterization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01822847
• Other study ID #: 12-16583
• Status: Completed
• Phase: N/A
• First received: March 28, 2013
• Last updated: February 24, 2015
• Start date: March 2013
• Est. completion date: April 2014

Study information

• Verified date: February 2015
• Source: Creighton University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 90 Years

Eligibility

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)

Study Design

Observational Model: Case-Crossover, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Adrenal Insufficiency

Locations

Country	Name	City	State
United States	Creighton University	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Creighton University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cortisol change	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	one month	No