Skip to main content
OpenTrials
Completed

NCT Number: NCT01144065

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

30 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Meir Medical Center

Kfar Saba, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Hair sampling for the measurement of cortisol and testosterone

Procedure

Hair sampling for the measurement of cortisol and testosterone

Primary outcomes

  1. Comparison of hair cortisol and testosterone levels between the patients with acute MI and the 2 control groups

    Time frame: 1 day

    The study does not include a follow-up period

Secondary outcomes

  1. Correlation of hair cortisol and testosterone with the burden of coronary atherosclerosis in the MI group

    Time frame: 1 day

    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

Sponsors and collaborators

Lead sponsor

Meir Medical Center

Other

Registry information

Official study title

A Comparison of Hair Cortisol and Testosterone Levels in Patients With Acute MI and Controls With and Without Chronic Cardiovascular Disease or Diabetes

Important dates

Study start
2010
First posted
Jun 15, 2010
Registry last updated
May 16, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.