Hair Cortisol and Testosterone Levels in Patients With and Without Acute Myocardial Infarction(MI)
A Comparison of Hair Cortisol and Testosterone Levels in Patients With Acute MI and Controls With and Without Chronic Cardiovascular Disease or Diabetes
1 other identifier
observational
180
1 country
1
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.
Trial Health
Trial Health Score
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participants targeted
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 7, 2010
CompletedFirst Posted
Study publicly available on registry
June 15, 2010
CompletedStudy Start
First participant enrolled
August 1, 2010
CompletedMay 16, 2012
May 1, 2012
June 7, 2010
May 15, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Comparison of hair cortisol and testosterone levels between the patients with acute MI and the 2 control groups
The study does not include a follow-up period
1 day
Secondary Outcomes (1)
Correlation of hair cortisol and testosterone with the burden of coronary atherosclerosis in the MI group
1 day
Study Arms (3)
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
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.
Patients without prior cardiovascular disease or diabetes
These patients do not have acute coronary syndrome or stroke Prior cardiovascular disease (CVD) or diabetes
Interventions
Hair sampling for the measurement of cortisol and testosterone
Eligibility Criteria
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
You may qualify if:
- 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).
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Meir Medical Center
Kfar Saba, Israel, Israel
Related Publications (5)
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.
PMID: 17892760BACKGROUNDVan 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.
PMID: 18609301BACKGROUNDBrotman 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.
PMID: 17822755BACKGROUNDKhaw 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.
PMID: 18040028BACKGROUNDMuller 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.
PMID: 15096452BACKGROUND
Biospecimen
Heir samples for the measurement of cortisol and testosterone
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Pereg
Meir Medical Center
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 7, 2010
First Posted
June 15, 2010
Study Start
August 1, 2010
Last Updated
May 16, 2012
Record last verified: 2012-05