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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04924426
Other study ID # RECHMPL21_0283
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 1, 2021
Est. completion date August 30, 2022

Study information

Verified date June 2021
Source University Hospital, Montpellier
Contact Manon Blanc, resident
Phone 06-15-63-14-58
Email ma-blanc@chu-montpellier.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Ischemic heart disease is the leading cause of death worldwide and the leading cause of sudden cardiac death. However, its post-mortem diagnosis is particularly difficult because the gross examination of the heart is usually normal at the autopsy . The diagnosis is therefore often based on a set of indirect arguments, such as the patient's medical and clinical history and the degree of occlusion of the coronary arteries. The formal diagnosis of acute myocardial infarction (AMI) currently relies on standard histological examination. However, histological findings often require a prolonged survival time of several hours to be highlighted. Triphenyltetrazolium chloride (TTC) is a salt that reacts with lactate dehydrogenases contained in still viable myocardial cells, forming a red pigment visible to the naked eye, (1,3,5 triphenylformazan). Ischemia-induced cell death, which occurs within minutes of the causative event, is responsible for the leakage of lactate deshydrogenase into the extracellular medium and thus results in the absence of formazan formation in the infarcted area, which displays an easily identifiable pale unstained color. It has been suggested that the use of TTC would allow the identification of MI as early as one hour of survival in animal models, before the usual macroscopic and microscopic signs are visible. It could therefore represent an attractive forensic tool for the early diagnosis of AMI at the autopsy.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date August 30, 2022
Est. primary completion date August 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria: - Adult patients autopsied at the Forensic Institute of the CHU of MONTPELLIER whose ante-mortem (medical history, cardiovascular risk factors, clinical history) and autopsy data (significant coronary stenosis associated or not with an endoluminal thrombus, scars of old infarction, absence of other identified cause of death) suggest AMI as the cause of death. - Known survival time and postmortem interval. Exclusion criteria: - Putrefied bodies

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
TTC immersion
TTC immersion

Locations

Country Name City State
France Uhmontpellier Montpellier

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Negative colorimetric reaction to TTC of infarcted myocardial tissue Negative colorimetric reaction to TTC of infarcted myocardial tissue day 1
Secondary Survival time (time from initial symptoms to death) Survival time (time from initial symptoms to death) day 1
Secondary Post-mortem interval (time from death to autopsy) Post-mortem interval (time from death to autopsy) day 1
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