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Clinical Trials/NCT05446779
NCT05446779
Active, not recruiting
Not Applicable

Postmortem Evaluation of Adrenal and Other Endocrine Tumors in Patients With Sudden Death Without Definitive Causative Diagnosis (PEA-SuddenDeath)

Helsinki University Central Hospital1 site in 1 country400 target enrollmentFebruary 3, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Primary Aldosteronism
Sponsor
Helsinki University Central Hospital
Enrollment
400
Locations
1
Primary Endpoint
CYP11B1 staining in adrenal glands
Status
Active, not recruiting
Last Updated
2 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
February 3, 2022
End Date
December 31, 2026
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Niina Matikainen

M.D., Ph.D, , Assoc. Prof.

Helsinki University Central Hospital

Eligibility Criteria

Inclusion Criteria

  • Consecutive patients with out-of-hospital, sudden death

Exclusion Criteria

  • 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)
  • Terminal disease
  • Institutionalized patients

Outcomes

Primary Outcomes

CYP11B1 staining in adrenal glands

Time Frame: Through study completion, an average of 2 years

Histopathological diagnosis of the autopsy

CYP11B2 staining in adrenal glands

Time Frame: Through study completion, an average of 2 years

Histopathological diagnosis of the autopsy

Secondary Outcomes

  • CYP11B2 staining in adrenal glands(Through study completion, an average of 2 years)
  • Pheochromocytoma or paraganglioma(Through study completion, an average of 2 years)
  • Neuroendocrine tumor(Through study completion, an average of 2 years)

Study Sites (1)

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