NCT00682487

Brief 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. 1.Introduction of the study to the participants and inform consent signing
  2. 2.Collection of clinical and demographic data
  3. 3.Scalp hair sampling- samples will be sent for laboratory analysis
  4. 4.Analysis of the results

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 22, 2008

Completed
10 days until next milestone

Study Start

First participant enrolled

June 1, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

June 19, 2009

Status Verified

April 1, 2009

Enrollment Period

10 months

First QC Date

May 20, 2008

Last Update Submit

June 18, 2009

Conditions

Acute Myocardial Infarction

Keywords

Myocardial infarctionStressHair Cortisol

Outcome Measures

Primary Outcomes (1)

  • hair cortisol levels in patients admitted with acute MI compared to controls

    at enrollment

Secondary Outcomes (1)

  • the association between hair cortisol levels and the prognosis of patients with acute MI.

    at enrollment

Study Arms (2)

1

patients admitted to the cardiology department with acute Myocardial infarction.

Other: Hair sampling for cortisol

2

patients admitted to an internal medicine department due to reasons other than an acute thrombotic event

Other: Hair sampling for cortisol

Interventions

Hair sampling for cortisolOTHER

Hair sampling for cortisol

1

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir Medical Center

Kfar Saba, Israel

Location

Related Publications (5)

  • 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.

    PMID: 17822755BACKGROUND

  • Yamada 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.

    PMID: 17356304BACKGROUND

  • 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.

    PMID: 17892760BACKGROUND

  • Kalra 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.

    PMID: 17716540BACKGROUND

  • Davenport 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.

    PMID: 16483573BACKGROUND

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Hydrocortisone

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds11-HydroxycorticosteroidsHydroxycorticosteroidsAdrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists17-Hydroxycorticosteroids

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 20, 2008

First Posted

May 22, 2008

Study Start

June 1, 2008

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

June 19, 2009

Record last verified: 2009-04

Locations

IL(1)