Acute Myocardial InfarctionNCT01144065
Hair Cortisol and Testosterone Levels in Patients With and Without Acute Myocardial Infarction(MI)
An observational study of Acute Myocardial Infarction, run by Meir Medical Center at 1 site in Israel.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 years and older, men only
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- Hair sampling for the measurement of cortisol and testosterone
- Type of treatment
- Surgery or procedure
- How many people
- 180 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2010to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- General:
- Males
- Age>30
- Cases:
- Patients with acute MI ( elevated cardiac enzymes + chest pain or typical ECG changes)
- Control group 1:
Show all 11Show fewer
- 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).
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Acute Myocardial Infarction
- Being tested
- Hair sampling for the measurement of cortisol and testosterone
- Keywords
- Myocardial infarction, Cortisol, Testosterone
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hair sampling for the measurement of cortisol and testosteroneProcedure or surgery
Hair sampling for the measurement of cortisol and testosterone
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: 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. Receives: Procedure: 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 Receives: Procedure: Hair sampling for the measurement of cortisol and testosterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of hair cortisol and testosterone levels between the patients with acute MI and the 2 control groups
The study does not include a follow-up period
Measured: 1 day
Secondary outcomes (1)
Correlation of hair cortisol and testosterone with the burden of coronary atherosclerosis in the MI group
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
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2010 (estimated)
- Study startAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Pereg, Principal investigator, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01144065
- Sponsor's protocol ID
- HCT-1
- Status last verified
- May 2012
- First submitted
- 7 Jun 2010
- Last updated
- 16 May 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Sauve B, Koren G, Walsh G, Tokmakejian S, Van Uum SH. Measurement of cortisol in human hair as a biomarker of systemic exposure. Clin Invest Med. 2007;30(5):E183-91. doi: 10.25011/cim.v30i5.2894.
PubMed 17892760Van Uum SH, Sauve B, Fraser LA, Morley-Forster P, Paul TL, Koren G. Elevated content of cortisol in hair of patients with severe chronic pain: a novel biomarker for stress. Stress. 2008 Nov;11(6):483-8. doi: 10.1080/10253890801887388.
PubMed 18609301Brotman DJ, Golden SH, Wittstein IS. The cardiovascular toll of stress. Lancet. 2007 Sep 22;370(9592):1089-100. doi: 10.1016/S0140-6736(07)61305-1.
PubMed 17822755Khaw KT, Dowsett M, Folkerd E, Bingham S, Wareham N, Luben R, Welch A, Day N. Endogenous testosterone and mortality due to all causes, cardiovascular disease, and cancer in men: European prospective investigation into cancer in Norfolk (EPIC-Norfolk) Prospective Population Study. Circulation. 2007 Dec 4;116(23):2694-701. doi: 10.1161/CIRCULATIONAHA.107.719005. Epub 2007 Nov 26.
PubMed 18040028Muller M, van den Beld AW, Bots ML, Grobbee DE, Lamberts SW, van der Schouw YT. Endogenous sex hormones and progression of carotid atherosclerosis in elderly men. Circulation. 2004 May 4;109(17):2074-9. doi: 10.1161/01.CIR.0000125854.51637.06. Epub 2004 Apr 19.
PubMed 15096452
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01144065
- Acronym / sponsor ID
- HCT-1
- Conditions
- Acute Myocardial Infarction
- Keywords
- Myocardial infarction, Cortisol, Testosterone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Aug 2010
- First posted
- 15 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patient with acute MI | – | Procedure: Hair sampling for the measurement of cortisol and testosteronePatients with acute MI ( elevated cardiac enzymes + chest pain or typical ECG changes)admitted to the cardiology department at Meir Medical Center |
| Patient with prior cardiovascular disease and/or diabetes | – | Procedure: Hair sampling for the measurement of cortisol and testosteroneThese 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. |
| Patients without prior cardiovascular disease or diabetes | – | Procedure: Hair sampling for the measurement of cortisol and testosteroneThese patients do not have acute coronary syndrome or stroke Prior cardiovascular disease (CVD) or diabetes |
Who may qualify
- Ages
- 30 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (11 listed)
- Males
- Age>30
- Patients with acute MI ( elevated cardiac enzymes + chest pain or typical ECG changes)
- 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)
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hair sampling for the measurement of cortisol and testosteroneHair sampling for the measurement of cortisol and testosterone | Procedure or surgery | Patient with acute MI, Patient with prior cardiovascular disease and/or diabetes, Patients without prior cardiovascular disease or diabetes |
Primary outcome
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
1 secondary outcome
Correlation of hair cortisol and testosterone with the burden of coronary atherosclerosis in the MI group
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2012.
- Background: PubMed 17892760Sauve B, Koren G, Walsh G, Tokmakejian S, Van Uum SH. Measurement of cortisol in human hair as a biomarker of systemic exposure. Clin Invest Med. 2007;30(5):E183-91. doi: 10.25011/cim.v30i5.2894.
- Background: PubMed 18609301Van Uum SH, Sauve B, Fraser LA, Morley-Forster P, Paul TL, Koren G. Elevated content of cortisol in hair of patients with severe chronic pain: a novel biomarker for stress. Stress. 2008 Nov;11(6):483-8. doi: 10.1080/10253890801887388.
- Background: PubMed 17822755Brotman DJ, Golden SH, Wittstein IS. The cardiovascular toll of stress. Lancet. 2007 Sep 22;370(9592):1089-100. doi: 10.1016/S0140-6736(07)61305-1.
- Background: PubMed 18040028Khaw KT, Dowsett M, Folkerd E, Bingham S, Wareham N, Luben R, Welch A, Day N. Endogenous testosterone and mortality due to all causes, cardiovascular disease, and cancer in men: European prospective investigation into cancer in Norfolk (EPIC-Norfolk) Prospective Population Study. Circulation. 2007 Dec 4;116(23):2694-701. doi: 10.1161/CIRCULATIONAHA.107.719005. Epub 2007 Nov 26.
- Background: PubMed 15096452Muller M, van den Beld AW, Bots ML, Grobbee DE, Lamberts SW, van der Schouw YT. Endogenous sex hormones and progression of carotid atherosclerosis in elderly men. Circulation. 2004 May 4;109(17):2074-9. doi: 10.1161/01.CIR.0000125854.51637.06. Epub 2004 Apr 19.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Pereg principal investigator
Meir Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myocardial Infarction, run by Meir Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of hair cortisol and testosterone levels between the patients with acute MI and the 2 control groups (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01144065, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2012.