Adrenal InsufficiencyNCT01822847
Physiological Response of Cortisol to Cardiac Catheterization
An observational study of Adrenal Insufficiency, run by Creighton University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Adrenal Insufficiency
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Apr 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 30 males and females, age 20-90 years who are scheduled for elective cardiac catheterization procedure.
Who may be able to join
- Patients undergoing elective cardiac catheterization, who are willing and able to give consent.
Who cannot join
- • 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Adrenal Insufficiency
- Keywords
- adrenal, steroids, cortisol, stress
- Medical subject headings
- Adrenal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| catheterization | patients undergoing elective heart catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adrenal InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Creighton University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valentina Tarasova, MD, Principal investigator, Creighton University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01822847
- Sponsor's protocol ID
- 12-16583
- Status last verified
- Feb 2015
- First submitted
- 28 Mar 2013
- Last updated
- 26 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Response of Cortisol to Cardiac Catheterization
- ClinicalTrials.gov ID
- NCT01822847
- Acronym / sponsor ID
- 12-16583
- Conditions
- Adrenal Insufficiency
- Keywords
- adrenal, steroids, cortisol, stress
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Creighton UniversityUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 2 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| catheterization | – | –patients undergoing elective heart catheterization |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 30 males and females, age 20-90 years who are scheduled for elective cardiac catheterization procedure.
Key inclusion criteria (1 listed)
- Patients undergoing elective cardiac catheterization, who are willing and able to give consent.
Key exclusion criteria (4 listed)
- • Patients with .primary or secondary adrenal insufficiency.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valentina Tarasova, MD principal investigator
Creighton University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adrenal Insufficiency, run by Creighton University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cortisol change (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2015.