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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01144065
First received: June 7, 2010
Last updated: May 15, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention
Acute Myocardial Infarction
Procedure: Hair sampling for the measurement of cortisol and testosterone

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Comparison of Hair Cortisol and Testosterone Levels in Patients With Acute MI and Controls With and Without Chronic Cardiovascular Disease or Diabetes

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • Comparison of hair cortisol and testosterone levels between the patients with acute MI and the 2 control groups [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    The study does not include a follow-up period


Secondary Outcome Measures:
  • Correlation of hair cortisol and testosterone with the burden of coronary atherosclerosis in the MI group [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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


Biospecimen Retention:   Samples Without DNA

Heir samples for the measurement of cortisol and testosterone


Enrollment: 180
Study Start Date: August 2010
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Criteria

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)
  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: NCT01144065

Locations
Israel
Meir Medical Center
Kfar-Saba, Israel
Sponsors and Collaborators
Meir Medical Center
Investigators
Principal Investigator: David Pereg Meir Medical Center
  More Information

Publications:
Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01144065     History of Changes
Other Study ID Numbers: HCT-1
Study First Received: June 7, 2010
Last Updated: May 15, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Meir Medical Center:
Myocardial infarction
Cortisol
Testosterone

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases
Cortisol succinate
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone-17-butyrate
Methyltestosterone
Testosterone
Testosterone 17 beta-cypionate
Testosterone enanthate
Testosterone undecanoate
Anabolic Agents
Androgens
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Dermatologic Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014