Clinical trial NCT01144065: Hair Cortisol and Testosterone Levels in Patients With and Without Acute Myocardial Infarction(MI)
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myocardial Infarction
Keywords: Myocardial infarction
Cortisol
Testosterone
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2010-06-15
Enrollment: 180
Sex: MALE
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cases:

Patient with acute MI admitted to the cardiology department at Meir Medical Center

Controls:

Control group 1:

patients with prior cardiovascular disease and/or diabetes:from intrnal medicine ward and the outpatient clinic

Control group 2:

Patients without prior cardiovascular disease or diabetes:from intrnal medicine ward and the outpatient clinic

Brief 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.

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 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)

Primary outcomes:
measure: Comparison of hair cortisol and testosterone levels between the patients with acute MI and the 2 control groups
timeFrame: 1 day
Secondary outcomes:
measure: Correlation of hair cortisol and testosterone with the burden of coronary atherosclerosis in the MI group
timeFrame: 1 day
Other outcomes:
Locations:
city: Kfar-Saba
country: Israel
facility: Meir Medical Center
Study officials:
affiliation: Meir Medical Center
name: David Pereg
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sauve 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. doi: 10.25011/cim.v30i5.2894.
citation: Van Uum SH, Sauve 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.
citation: Brotman DJ, Golden SH, Wittstein IS. The cardiovascular toll of stress. Lancet. 2007 Sep 22;370(9592):1089-100. doi: 10.1016/S0140-6736(07)61305-1.
citation: 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. doi: 10.1161/CIRCULATIONAHA.107.719005. Epub 2007 Nov 26.
citation: 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. doi: 10.1161/01.CIR.0000125854.51637.06. Epub 2004 Apr 19.