Hair Cortisol and the Risk of Acute Myocardial Infarction

Sponsor
Meir Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT00682487
Collaborator
(none)
120
1
10
12

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Hair sampling for cortisol
  • Other: Hair sampling for cortisol

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 Design

Study Type:
Observational
Actual Enrollment :
120 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Hair Cortisol and the Risk of Acute Myocardial Infarction
Study Start Date :
Jun 1, 2008
Actual Primary Completion Date :
Apr 1, 2009
Actual Study Completion Date :
Apr 1, 2009

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. hair cortisol levels in patients admitted with acute MI compared to controls [at enrollment]

Secondary Outcome Measures

  1. the association between hair cortisol levels and the prognosis of patients with acute MI. [at enrollment]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Meir Medical Center Kfar Sava Israel

Sponsors and Collaborators

  • Meir Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00682487
Other Study ID Numbers:
  • 0246-07-MMC
First Posted:
May 22, 2008
Last Update Posted:
Jun 19, 2009
Last Verified:
Apr 1, 2009

Study Results

No Results Posted as of Jun 19, 2009