Hair Cortisol and the Risk of Acute Myocardial Infarction

This study has been completed.
Sponsor:
Information provided by:
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT00682487
First received: May 20, 2008
Last updated: June 18, 2009
Last verified: April 2009
  Purpose

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 Intervention
Acute Myocardial Infarction
Other: Hair sampling for cortisol

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Hair Cortisol and the Risk of Acute Myocardial Infarction

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • hair cortisol levels in patients admitted with acute MI compared to controls [ Time Frame: at enrollment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • the association between hair cortisol levels and the prognosis of patients with acute MI. [ Time Frame: at enrollment ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: June 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00682487

Locations
Israel
Meir Medical Center
Kfar Sava, Israel
Sponsors and Collaborators
Meir Medical Center
  More Information

Publications:
Responsible Party: Dr David Pereg, Department of Internal Medicine A and Cardiology devision, Meir Medical Center
ClinicalTrials.gov Identifier: NCT00682487     History of Changes
Other Study ID Numbers: 0246-07-MMC
Study First Received: May 20, 2008
Last Updated: June 18, 2009
Health Authority: Israel: Ethics Commission

Keywords provided by Meir Medical Center:
Myocardial infarction
Stress
Hair Cortisol

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
Cortisol succinate
Hydrocortisone
Hydrocortisone-17-butyrate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Dermatologic Agents

ClinicalTrials.gov processed this record on July 31, 2014