INFARCTOPSY: Interest of TTC for the Early Diagnosis of Acute Myocardial Infarction at Autopsy

Sponsor
University Hospital, Montpellier (Other)
Overall Status
Recruiting
CT.gov ID
NCT04924426
Collaborator
(none)
40
1
16
2.5

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: TTC immersion

Study Design

Study Type:
Observational
Anticipated Enrollment :
40 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Interest of Triphenyl Tetrazolium Chloride (TTC) for the Early Diagnosis of Acute Myocardial Infarction at Autopsy
Actual Study Start Date :
May 1, 2021
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Aug 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Patients with AMI

Patients with AMI

Procedure: TTC immersion
TTC immersion

Patients with no AMI

Patients with no AMI

Procedure: TTC immersion
TTC immersion

Outcome Measures

Primary Outcome Measures

  1. Negative colorimetric reaction to TTC of infarcted myocardial tissue [day 1]

    Negative colorimetric reaction to TTC of infarcted myocardial tissue

Secondary Outcome Measures

  1. Survival time (time from initial symptoms to death) [day 1]

    Survival time (time from initial symptoms to death)

  2. Post-mortem interval (time from death to autopsy) [day 1]

    Post-mortem interval (time from death to autopsy)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Uhmontpellier Montpellier France 34295

Sponsors and Collaborators

  • University Hospital, Montpellier

Investigators

  • Study Director: Pierre-Antoine Peyron, PH, University Hospital, Montpellier

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT04924426
Other Study ID Numbers:
  • RECHMPL21_0283
First Posted:
Jun 14, 2021
Last Update Posted:
Jun 14, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Montpellier
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 14, 2021