Acute Myocardial InfarctionNCT00682487
Hair Cortisol and the Risk of Acute Myocardial Infarction
An observational study of Acute Myocardial Infarction, run by Meir Medical Center at 1 site in Israel.
Trial summary
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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- Hair sampling for cortisol
- How many people
- 120 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2008to Apr 2009
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Cases- patients with acute MI ( elevated cardiac enzymes + chest pain or typical ECG changes)
- Controls- patients admitted to an internal medicine department due to reasons other than acute MI or stroke.
Who cannot join
- Corticosteroid treatment in the last 12 months
- Diagnosis or Cushing's or Addison's disease
- Treatment with hormone replacement therapy
- Treatment with oral contraceptives
- Colored heir
- Inability to sign inform consent
Trial locations and contacts
1 site in 1 country.
About this study
Aim of the study:
To evaluate whether hair cortisol levels are elevated in patients admitted with acute MI compared to controls.
Study steps:
- Introduction of the study to the participants and inform consent signing
- Collection of clinical and demographic data
- Scalp hair sampling- samples will be sent for laboratory analysis
- Analysis of the results
Read the 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.
- Conditions
- Acute Myocardial Infarction
- Being tested
- Hair sampling for cortisol
- Keywords
- Myocardial infarction, Stress, Hair Cortisol
- 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 cortisolOther
Hair sampling for cortisol
Hair sampling for cortisolOther
Hair sampling for cortisol
| Study group | Role | What they receive |
|---|---|---|
| 1 | patients admitted to the cardiology department with acute Myocardial infarction. Receives: Other: Hair sampling for cortisol | |
| 2 | patients admitted to an internal medicine department due to reasons other than an acute thrombotic event Receives: Other: Hair sampling for cortisol |
What is being measured
The primary outcome is the main question the study is designed to answer.
hair cortisol levels in patients admitted with acute MI compared to controls
Measured: at enrollment
Secondary outcomes (1)
the association between hair cortisol levels and the prognosis of patients with acute MI.
Measured: at enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2008 (estimated)
- Study startJun 2008
- Primary completionApr 2009
- Study completionApr 2009
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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00682487
- Sponsor's protocol ID
- 0246-07-MMC
- Status last verified
- Apr 2009
- First submitted
- 20 May 2008
- Last updated
- 19 Jun 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Brotman 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 17822755Yamada J, Stevens B, de Silva N, Gibbins S, Beyene J, Taddio A, Newman C, Koren G. Hair cortisol as a potential biologic marker of chronic stress in hospitalized neonates. Neonatology. 2007;92(1):42-9. doi: 10.1159/000100085. Epub 2007 Mar 14.
PubMed 17356304Sauve 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 17892760Kalra S, Einarson A, Karaskov T, Van Uum S, Koren G. The relationship between stress and hair cortisol in healthy pregnant women. Clin Invest Med. 2007;30(2):E103-7. doi: 10.25011/cim.v30i2.986.
PubMed 17716540Davenport MD, Tiefenbacher S, Lutz CK, Novak MA, Meyer JS. Analysis of endogenous cortisol concentrations in the hair of rhesus macaques. Gen Comp Endocrinol. 2006 Jul;147(3):255-61. doi: 10.1016/j.ygcen.2006.01.005. Epub 2006 Feb 17.
PubMed 16483573
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hair Cortisol and the Risk of Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT00682487
- Acronym / sponsor ID
- 0246-07-MMC
- Conditions
- Acute Myocardial Infarction
- Keywords
- Myocardial infarction, Stress, Hair Cortisol
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 22 May 2008 (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.
Aim of the study:
To evaluate whether hair cortisol levels are elevated in patients admitted with acute MI compared to controls.
Study steps:
- Introduction of the study to the participants and inform consent signing
- Collection of clinical and demographic data
- Scalp hair sampling- samples will be sent for laboratory analysis
- Analysis of the results
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: Hair sampling for cortisolpatients admitted to the cardiology department with acute Myocardial infarction. |
| 2 | – | Other: Hair sampling for cortisolpatients admitted to an internal medicine department due to reasons other than an acute thrombotic event |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Cases- patients with acute MI ( elevated cardiac enzymes + chest pain or typical ECG changes)
- Controls- patients admitted to an internal medicine department due to reasons other than acute MI or stroke.
Key exclusion criteria (6 listed)
- Corticosteroid treatment in the last 12 months
- Diagnosis or Cushing's or Addison's disease
- Treatment with hormone replacement therapy
- Treatment with oral contraceptives
- Colored heir
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 cortisolHair sampling for cortisol | Other | 1 |
| Hair sampling for cortisolHair sampling for cortisol | Other | 2 |
Primary outcome
hair cortisol levels in patients admitted with acute MI compared to controls
Time frame: at enrollment
1 secondary outcome
the association between hair cortisol levels and the prognosis of patients with acute MI.
Time frame: at enrollment
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 19 Jun 2009.
- 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 17356304Yamada J, Stevens B, de Silva N, Gibbins S, Beyene J, Taddio A, Newman C, Koren G. Hair cortisol as a potential biologic marker of chronic stress in hospitalized neonates. Neonatology. 2007;92(1):42-9. doi: 10.1159/000100085. Epub 2007 Mar 14.
- 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 17716540Kalra S, Einarson A, Karaskov T, Van Uum S, Koren G. The relationship between stress and hair cortisol in healthy pregnant women. Clin Invest Med. 2007;30(2):E103-7. doi: 10.25011/cim.v30i2.986.
- Background: PubMed 16483573Davenport MD, Tiefenbacher S, Lutz CK, Novak MA, Meyer JS. Analysis of endogenous cortisol concentrations in the hair of rhesus macaques. Gen Comp Endocrinol. 2006 Jul;147(3):255-61. doi: 10.1016/j.ygcen.2006.01.005. Epub 2006 Feb 17.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 2 inclusion and 6 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 19 Jun 2009. 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?
hair cortisol levels in patients admitted with acute MI compared to controls (time frame: at enrollment). 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 NCT00682487, 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 19 Jun 2009.