- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07285915
The Role of Stress in Cardiac Arrest (Cortizol CPR) (Cortizol)
Stress as a Key Factor Influencing the Onset and Course of Cardiac Arrest
Study Overview
Status
Intervention / Treatment
Detailed Description
Despite significant advances in resuscitation medicine, out-of-hospital cardiac arrest (OHCA) continues to carry a poor prognosis, with survival accompanied by good neurological outcomes in only about 30% of cases. In Europe, OHCA affects approximately 67-170 individuals per 100,000 annually; in the Czech Republic, the incidence is around 90 per 100,000. Most cardiac arrests (60-70%) are of cardiovascular origin, where long-term stress is a known contributing risk factor.
Chronic stress not only influences the development of cardiovascular disease but also affects its clinical manifestation by modulating the autonomic nervous system-an essential regulator of heart rhythm and arrhythmogenic risk. Therefore, it is plausible that prolonged stress also contributes to the onset and course of cardiac arrest.
While the relationship between chronic stress and cardiovascular disease has been well documented, data specifically linking stress to out-of-hospital cardiac arrest are still lacking. The pathophysiological factors influencing the onset and refractoriness of OHCA also remain unclear.
This study aims to evaluate chronic stress levels in patients after OHCA by measuring cortisol concentrations in hair samples. Since cortisol accumulates in hair during its growth, a 3 cm segment reflects stress exposure over the previous three months. These findings will be correlated with patients' demographic and clinical profiles, including post-resuscitation condition severity, neurological outcomes, and potential arrest refractoriness.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jana Smalcova, MD, Ph.D.
- Phone Number: +420 775 360 017
- Email: jana.smalcova@gmail.com
Study Contact Backup
- Name: Milan Hromadka, MD, Ph.D.
- Phone Number: +420 377 105 840
- Email: hromadka@fnplzen.cz
Study Locations
-
-
Czech Republic
-
Pilsen, Czech Republic, Czechia, 30100
- Recruiting
- University Hospital Pilsen
-
Contact:
- Jana Smalcova, MD, Ph.D.
- Phone Number: +420 775 360 017
- Email: jana.smalcova@gmail.com
-
Contact:
- Milan Hromadka, MD, Ph.D.
- Phone Number: +420 377 105 840
- Email: hromadka@fnplzen.cz
-
Principal Investigator:
- Jana Smalcova, MD, Ph.D.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Cardiac arrest
- Heart attack
- 18 - 100 years
Exclusion Criteria:
- Disapproval patient´s relatives with the study
- Chronical treatment with corticoids and antidepresives
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cardiac arrest
|
Sampling of 3cm of hair due to level of cortizol.
|
|
Experimental: Heart attack
|
Sampling of 3cm of hair due to level of cortizol.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hair cortisol levels assessment in CA patients vs heart attack patients
Time Frame: Enrollment
|
Hair cortisol levels assessment in CA patients vs heart attack patients
|
Enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Correlation of neurological outcomes using the CPC scale in CA patients with hair cortisol levels.
Time Frame: 30 and 90 days after CA
|
Correlation of neurological outcomes using the CPC scale in CA patients with hair cortisol levels.
|
30 and 90 days after CA
|
|
Correlation between the severity of the post-resuscitation course according to the severity of organ damage (heart, lung, kidneys, brain ) and hair cortisol levels
Time Frame: 30 days after CA
|
Correlation between the severity of the post-resuscitation course according to the severity of organ damage (heart, lung, kidneys, brain ) and hair cortisol levels
|
30 days after CA
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Stress
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cardiac Arrest (CA)
-
Centre Hospitalier Universitaire de NiceNot yet recruiting
-
Cliniques universitaires Saint-Luc- Université...Recruiting
-
Azienda Usl di BolognaNot yet recruiting
-
University of PecsRecruitingCardiac Arrest (CA)Hungary
-
Capital Medical UniversityNot yet recruiting
-
Amsterdam UMC, location VUmcNot yet recruiting
-
University of PecsCompletedCardiac Arrest (CA)Hungary
-
National Taiwan University HospitalChang Bing Show Chwan Memorial HospitalEnrolling by invitation
Clinical Trials on Sample of hair
-
Shalvata Mental Health CenterCompletedSchizophrenia | Schizo-Affective DisorderIsrael
-
University Hospital, BrestRecruitingSchizophrenia | Schizophrenia Prodromal | Schizophrenia, ChildhoodFrance
-
Assistance Publique - Hôpitaux de ParisCompletedCocaine-induced Psychotic Disorder During IntoxicationFrance
-
University Hospital, ToursNot yet recruiting
-
M.D. Anderson Cancer CenterTerminated
-
Poznan University of Medical SciencesUnknownGlucose Metabolism Disorders | Hypertension | Obesity | Nutrition Disorders | Metabolic Syndrome | Dyslipidemias | Glucose Intolerance | Overweight and ObesityPoland
-
Sohag UniversityNot yet recruiting
-
NovoBliss Research Pvt LtdCompleted
-
Nutraceutical Wellness Inc.CompletedHair ThinningUnited States