Hair Cortisol and Testosterone Levels in Patients With and Without Acute Myocardial Infarction(MI)

NCT ID: NCT01144065

Last Updated: 2012-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Myocardial Infarction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

Hair sampling for the measurement of cortisol and testosterone

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Hair sampling for the measurement of cortisol and testosterone

Hair sampling for the measurement of cortisol and testosterone

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

30 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Meir Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

David Pereg

Role: PRINCIPAL_INVESTIGATOR

Meir Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Meir Medical Center

Kfar Saba, Israel, Israel

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Israel

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 17892760 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18609301 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17822755 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18040028 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15096452 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HCT-1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.