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

May 15, 2012 updated by: Meir Medical Center

A Comparison of Hair Cortisol and Testosterone Levels in Patients With Acute MI and Controls With and Without Chronic Cardiovascular Disease or Diabetes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Kfar-Saba, Israel
        • Meir Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

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

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Procedure: 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.
Procedure: 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
Procedure: Hair sampling for the measurement of cortisol and testosterone
Hair sampling for the measurement of cortisol and testosterone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of hair cortisol and testosterone levels between the patients with acute MI and the 2 control groups
Time Frame: 1 day
The study does not include a follow-up period
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of hair cortisol and testosterone with the burden of coronary atherosclerosis in the MI group
Time Frame: 1 day
Coronary atherosclerosis will be quantitated in the MI patients that will undergo coronary angiography. We will evaluate the association of the atherosclerosis burden with Hair cortisol and testosterone levels
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meir Medical Center

Investigators

  • Principal Investigator: David Pereg, Meir Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Study Registration Dates

First Submitted

June 7, 2010

First Submitted That Met QC Criteria

June 14, 2010

First Posted (Estimate)

June 15, 2010

Study Record Updates

Last Update Posted (Estimate)

May 16, 2012

Last Update Submitted That Met QC Criteria

May 15, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCT-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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