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

Clalit Health Services

Status: Completed

Conditions: Acute Myocardial Infarction

Treatments: Procedure: Hair sampling for the measurement of cortisol and testosterone

Study type: Observational

Funder types: Other

Identifiers

NCT01144065

HCT-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 patients

Sex: Male

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

180 participants in 3 patient groups

Patient with acute MI

Description:

Patients with acute MI ( elevated cardiac enzymes + chest pain or typical ECG changes)admitted to the cardiology department at Meir Medical Center

Treatment:

Procedure: Hair sampling for the measurement of cortisol and testosterone

Patient with prior cardiovascular disease and/or diabetes

Description:

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.

Treatment:

Procedure: Hair sampling for the measurement of cortisol and testosterone

Patients without prior cardiovascular disease or diabetes

Description:

These patients do not have acute coronary syndrome or stroke Prior cardiovascular disease (CVD) or diabetes

Treatment:

Procedure: Hair sampling for the measurement of cortisol and testosterone