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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05446779
Other study ID # THL/5008/5.05.00/2021
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date February 3, 2022
Est. completion date December 31, 2026

Study information

Verified date April 2024
Source Helsinki University Central Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Sudden Cardiac Death is a leading cause of mortality and remains a major public health burden worldwide. Cardiac arrest due to coronary heart disease explains a large proportion of the cases, but if autopsy is not performed the exact underlying cause remains obscure in many adults who face sudden death outside heath care organizations. The investigators aim to find proof that primary aldosteronism is a risk factor for sudden death and to characterize the prevalence of adrenal pathology in sudden death of undetermined cause in a case-control study. In addition, the study aims to characterize the prevalence of other adrenal pathology i.e. silent adenomas, cortisol-producing adenomas and pheochromocytomas in sudden death. The investigators also seek evidence that other endocrine hormone overproduction-causing diseases are more prevalent in persons with sudden death compared with those experiencing traumatic or suicidal death sudden death.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 400
Est. completion date December 31, 2026
Est. primary completion date January 31, 2023
Accepts healthy volunteers No
Gender All
Age group 35 Years to 70 Years
Eligibility Inclusion Criteria: Consecutive patients with out-of-hospital, sudden death Exclusion Criteria: 1. Estimated time from death to refrigerator more than 24-48 hours and in the refrigerator time more than 7 days (susceptibility to excessive tissue breakdown) 2. Terminal disease 3. Institutionalized patients

Study Design


Intervention

Diagnostic Test:
Adrenal aldosterone synthase (CYP11B2) staining
Immunoshistochemical diagnosis of primary aldosteronism
Adrenal cortisol synthase (CYP11B1) staining
Immunoshistochemical diagnosis of adrenal hypercortisolism
Histopathological analysis
Diagnosis of any endocrine neoplasia other than primary aldosteronism or adrenal hypercortisolism

Locations

Country Name City State
Finland Endocrinology, Helsinki University Hospital and University of Helsinki Helsinki

Sponsors (5)

Lead Sponsor Collaborator
Helsinki University Central Hospital Finnish Institute for Health and Welfare, Tampere University, Tampere University Hospital, University of Helsinki

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary CYP11B2 staining in adrenal glands Histopathological diagnosis of the autopsy Through study completion, an average of 2 years
Primary CYP11B1 staining in adrenal glands Histopathological diagnosis of the autopsy Through study completion, an average of 2 years
Secondary CYP11B2 staining in adrenal glands Histopathological diagnosis of the autopsy Through study completion, an average of 2 years
Secondary Pheochromocytoma or paraganglioma Histopathological diagnosis of the autopsy Through study completion, an average of 2 years
Secondary Neuroendocrine tumor Histopathological diagnosis of the autopsy Through study completion, an average of 2 years
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