Hair Cortisol and Testosterone Levels in Patients With and Without Acute Myocardial Infarction(MI)
Information source: Meir Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Myocardial Infarction
Intervention: Hair sampling for the measurement of cortisol and testosterone (Procedure)
Phase: N/A
Status: Completed
Sponsored by: Meir Medical Center Official(s) and/or principal investigator(s): David Pereg, Principal Investigator, Affiliation: Meir Medical Center
Summary
The purpose of this study is to determine whether hair levels of cortisol and testosterone
are elevated in patients with acute MI compared to controls.
Clinical Details
Official title: A Comparison of Hair Cortisol and Testosterone Levels in Patients With Acute MI and Controls With and Without Chronic Cardiovascular Disease or Diabetes
Study design: Observational Model: Case Control, Time Perspective: Prospective
Primary outcome: Comparison of hair cortisol and testosterone levels between the patients with acute MI and the 2 control groups
Secondary outcome: Correlation of hair cortisol and testosterone with the burden of coronary atherosclerosis in the MI group
Detailed description:
Recently there has been a growing interest in measuring hair cortisol and testosterone
levels. Hair grows approximately 1 centimeter per month, and hair analysis accurately
reflects long-term endogenous production of these hormones. The association of elevated hair
cortisol levels with chronic stress has been reported in several studies. Furthermore, we
have recently demonstrated higher hair cortisol levels in patients admitted with acute
myocardial infarction compared with patients admitted for other indications (the manuscript
has recently been submitted for publication). Nevertheless it is still not clear whether
hair cortisol levels are a risk factor for acute coronary event or for chronic
cardiovascular diseases. In order to address this issue, further comparison of hair cortisol
levels between patients with acute MI and a control group of patients with chronic
cardiovascular diseases is needed.
Several studied have reported that endogenous testosterone concentrations are inversely
associated with cardiovascular mortality and progression of atherosclerosis both in the
coronary and the peripheral arteries. However these studies used a single serum testosterone
level and therefore may not accurately represent the chronic endogenous production of this
hormone. It may be that the association of testosterone levels and cardiovascular disease
may be better evaluated using the hair technique. Nevertheless this association has not been
studied yet.
Aim of the study:
To compare hair cortisol and testosterone levels in patients admitted with acute MI to
stable patients with prior cardiovascular diseases or diabetes and patients with no history
of cardiovascular diseases.
Secondary endpoint:
To evaluate the association between hair cortisol and testosterone with the burden of
coronary atherosclerosis. The latter will be quantified only in the AMI patients undergoing
coronary angiography by assessing the non culprit coronary arteries.
Eligibility
Minimum age: 30 Years.
Maximum age: N/A.
Gender(s): Male.
Criteria:
Inclusion Criteria:
General:
- Males
- Age>30
Cases:
- Patients with acute MI ( elevated cardiac enzymes + chest pain or typical ECG
changes)
Control group 1:
Will include patients with at least 1 of the following:
- Prior cardiovascular disease (CVD). CVD is defined as a history of hospital admission
due to acute coronary artery occlusion, percutaneous coronary interventions (PCI),
coronary artery bypass grafting, any aortic or peripheral vascular disease that was
either symptomatic or required intervention, ischemic or hemorrhagic stroke or
transient ischemic attack.
- Diabetes mellitus. (Defined when it is reported by the patient or appears in his
medical records, or if the patient has received regular treatment with oral
hypoglycemic agents or insulin)
Control group 2:
- Patients without prior cardiovascular disease or diabetes mellitus (see definitions
above).
Exclusion Criteria:
- Corticosteroid treatment in the last 12 months.
- Diagnosis of Cushing's or Addison's disease.
- Diagnosed hypogonadism treated with testosterone
- Dyed hair.
- Inability to sign inform consent.
- Any hospital admission during the 6 months prior to enrolment
- Morbid obesity (BMI>35)
Locations and Contacts
Meir Medical Center, Kfar-Saba, Israel
Additional Information
Related publications: Sauvé B, Koren G, Walsh G, Tokmakejian S, Van Uum SH. Measurement of cortisol in human hair as a biomarker of systemic exposure. Clin Invest Med. 2007;30(5):E183-91. Van Uum SH, Sauvé B, Fraser LA, Morley-Forster P, Paul TL, Koren G. Elevated content of cortisol in hair of patients with severe chronic pain: a novel biomarker for stress. Stress. 2008 Nov;11(6):483-8. doi: 10.1080/10253890801887388. Brotman DJ, Golden SH, Wittstein IS. The cardiovascular toll of stress. Lancet. 2007 Sep 22;370(9592):1089-100. Review. Erratum in: Lancet. 2007 Dec 1;370(9602):1828. Khaw KT, Dowsett M, Folkerd E, Bingham S, Wareham N, Luben R, Welch A, Day N. Endogenous testosterone and mortality due to all causes, cardiovascular disease, and cancer in men: European prospective investigation into cancer in Norfolk (EPIC-Norfolk) Prospective Population Study. Circulation. 2007 Dec 4;116(23):2694-701. Epub 2007 Nov 26. Muller M, van den Beld AW, Bots ML, Grobbee DE, Lamberts SW, van der Schouw YT. Endogenous sex hormones and progression of carotid atherosclerosis in elderly men. Circulation. 2004 May 4;109(17):2074-9. Epub 2004 Apr 19.
Starting date: August 2010
Last updated: May 15, 2012
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