Hair Cortisol and the Risk of Acute Myocardial Infarction

June 18, 2009 updated by: Meir Medical Center

Aim of the study:

To evaluate whether hair cortisol levels are elevated in patients admitted with acute MI compared to controls.

Study steps:

  1. Introduction of the study to the participants and inform consent signing
  2. Collection of clinical and demographic data
  3. Scalp hair sampling- samples will be sent for laboratory analysis
  4. Analysis of the results

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Acute physical stressors such as surgery, trauma and intense physical exertion are well-known triggers of cardiovascular events. The connection between acute emotional stress and the heart has been controversial for many years. However, emotional stressors are now increasingly recognized as precipitants of cardiovascular events including myocardial infarction (MI). For example, on the day of the Los Angeles earthquake in 1994 the number of cardiac deaths and hospital admissions for acute myocardial infarction was 2-5 times higher than the usual rate. Furthermore, the risk of myocardial infarction in the short period following an acute emotional stress such as anger outburst, seems to be twice that of other periods and may be a more common precipitant than physical exertion1. While the association between acute stress and cardiovascular mortality and morbidity is well established, controversy still exists whether there is the same association with chronic stress, both physical and emotional. Data regarding this question are extremely limited since there has been no objective and reliable mode for the assessment of physical stress and for the quantification of overall chronic stress. Furthermore, the fact that all the information regarding the association between chronic stress and acute MI derives from retrospective studies further complicates this issue.

Both physical and emotional stress activate several neuroendocrine systems, the most important being the hypothalamic-pituitary-adrenal axis that stimulates the production and secretion of glucocorticoids (especially cortisol) from the adrenal cortex. Therefore, cortisol is considered to be a "stress hormone" and higher levels of serum cortisol have been observed in patients with acute stress such as those presented with acute MI, compared to healthy controls.

Currently, there are several modalities for measuring cortisol levels including serum, urinary and salivary techniques. However, all these methods represent indicators of acute stress and do not reflect accumulation of stress over time.

Recently there has been a growing interest in measuring hair cortisol level. Hair grows approximately 1 centimeter per month, and hair analysis accurately reflects long-term endogenous production of cortisol. This provides for the first time a reliable mode for the measurement of the accumulation of cortisol over time and a potential biomarker of chronic stress. Indeed, several reports have demonstrated an association between high hair cortisol levels and chronic stress in both animal models and in humans. Nevertheless, the possible association between hair cortisol and the risk of acute MI has not been studied yet.

Aim of the study:

To evaluate whether hair cortisol levels are elevated in patients admitted with acute MI compared to controls.

Study Type

Observational

Enrollment (Actual)

120

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 Sava, 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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

Cases: Patients admitted to the cardiology department due to acute myocardial infarction Controls: Patiens admitted ro an Internal Medicine department due to non-thrombotic disease.

Description

Inclusion Criteria:

  1. Cases- patients with acute MI ( elevated cardiac enzymes + chest pain or typical ECG changes)
  2. Controls- patients admitted to an internal medicine department due to reasons other than acute MI or stroke.

Exclusion Criteria:

  1. Corticosteroid treatment in the last 12 months
  2. Diagnosis or Cushing's or Addison's disease
  3. Treatment with hormone replacement therapy
  4. Treatment with oral contraceptives
  5. Colored heir
  6. Inability to sign inform consent

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
1
patients admitted to the cardiology department with acute Myocardial infarction.
Other: Hair sampling for cortisol
Hair sampling for cortisol
2
patients admitted to an internal medicine department due to reasons other than an acute thrombotic event
Other: Hair sampling for cortisol
Hair sampling for cortisol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
hair cortisol levels in patients admitted with acute MI compared to controls
Time Frame: at enrollment
at enrollment

Secondary Outcome Measures

Outcome Measure
Time Frame
the association between hair cortisol levels and the prognosis of patients with acute MI.
Time Frame: at enrollment
at enrollment

Collaborators and Investigators

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

Sponsor

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

June 1, 2008

Primary Completion (ACTUAL)

April 1, 2009

Study Completion (ACTUAL)

April 1, 2009

Study Registration Dates

First Submitted

May 20, 2008

First Submitted That Met QC Criteria

May 20, 2008

First Posted (ESTIMATE)

May 22, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

June 19, 2009

Last Update Submitted That Met QC Criteria

June 18, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0246-07-MMC

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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