Hair Cortisol and Testosterone Levels in Patients With and Without Acute Myocardial Infarction(MI)
NCT ID: NCT01144065
Last Updated: 2012-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
180 participants
OBSERVATIONAL
2010-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Patient with acute MI
Patients with acute MI ( elevated cardiac enzymes + chest pain or typical ECG changes)admitted to the cardiology department at Meir Medical Center
Hair sampling for the measurement of cortisol and testosterone
Hair sampling for the measurement of cortisol and testosterone
Patient with prior cardiovascular disease and/or diabetes
These patients do not have acute coronary syndrome or stroke. Prior cardiovascular disease (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.
Hair sampling for the measurement of cortisol and testosterone
Hair sampling for the measurement of cortisol and testosterone
Patients without prior cardiovascular disease or diabetes
These patients do not have acute coronary syndrome or stroke Prior cardiovascular disease (CVD) or diabetes
Hair sampling for the measurement of cortisol and testosterone
Hair sampling for the measurement of cortisol and testosterone
Interventions
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Hair sampling for the measurement of cortisol and testosterone
Hair sampling for the measurement of cortisol and testosterone
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
30 Years
MALE
No
Sponsors
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Meir Medical Center
OTHER
Responsible Party
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Principal Investigators
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David Pereg
Role: PRINCIPAL_INVESTIGATOR
Meir Medical Center
Locations
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Meir Medical Center
Kfar Saba, Israel, Israel
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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HCT-1
Identifier Type: -
Identifier Source: org_study_id
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