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Hair Cortisol and the Risk of Acute Myocardial Infarction

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ClinicalTrials.gov Identifier: NCT00682487
Recruitment Status : Completed
First Posted : May 22, 2008
Last Update Posted : June 19, 2009
Sponsor:
Information provided by:
Meir Medical Center

Tracking Information
First Submitted Date May 20, 2008
First Posted Date May 22, 2008
Last Update Posted Date June 19, 2009
Study Start Date June 2008
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 20, 2008)
hair cortisol levels in patients admitted with acute MI compared to controls [ Time Frame: at enrollment ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 20, 2008)
the association between hair cortisol levels and the prognosis of patients with acute MI. [ Time Frame: at enrollment ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Hair Cortisol and the Risk of Acute Myocardial Infarction
Official Title Hair Cortisol and the Risk of Acute Myocardial Infarction
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
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
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Acute Myocardial Infarction
Intervention Other: Hair sampling for cortisol
Hair sampling for cortisol
Study Groups/Cohorts
  • 1
    patients admitted to the cardiology department with acute Myocardial infarction.
    Intervention: Other: Hair sampling for cortisol
  • 2
    patients admitted to an internal medicine department due to reasons other than an acute thrombotic event
    Intervention: Other: Hair sampling for cortisol
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 9, 2009)
120
Original Estimated Enrollment
 (submitted: May 20, 2008)
160
Actual Study Completion Date April 2009
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: Male
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Israel
Removed Location Countries  
 
Administrative Information
NCT Number NCT00682487
Other Study ID Numbers 0246-07-MMC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dr David Pereg, Department of Internal Medicine A and Cardiology devision, Meir Medical Center
Study Sponsor Meir Medical Center
Collaborators Not Provided
Investigators Not Provided
PRS Account Meir Medical Center
Verification Date April 2009