NCT04924426

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 10, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 14, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2022

Completed
Last Updated

June 14, 2021

Status Verified

June 1, 2021

Enrollment Period

1.3 years

First QC Date

June 10, 2021

Last Update Submit

June 10, 2021

Conditions

Keywords

Early Acute Myocardial InfarctionTTCSudden deathEarly markersbiochemicla markers

Outcome Measures

Primary Outcomes (1)

  • Negative colorimetric reaction to TTC of infarcted myocardial tissue

    Negative colorimetric reaction to TTC of infarcted myocardial tissue

    day 1

Secondary Outcomes (2)

  • Survival time (time from initial symptoms to death)

    day 1

  • Post-mortem interval (time from death to autopsy)

    day 1

Study Arms (2)

Patients with AMI

Patients with AMI

Procedure: TTC immersion

Patients with no AMI

Patients with no AMI

Procedure: TTC immersion

Interventions

TTC immersionPROCEDURE

TTC immersion

Patients with AMIPatients with no AMI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Suspicion of death due to acute myocardial infarction

You may qualify if:

  • 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.

You may not qualify if:

  • \- Putrefied bodies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

myocardial fragments

MeSH Terms

Conditions

Myocardial InfarctionDeath, Sudden

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisDeath

Study Officials

  • Pierre-Antoine Peyron, PH

    University Hospital, Montpellier

    STUDY DIRECTOR

Central Study Contacts

Manon Blanc, resident

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2021

First Posted

June 14, 2021

Study Start

May 1, 2021

Primary Completion

August 1, 2022

Study Completion

August 30, 2022

Last Updated

June 14, 2021

Record last verified: 2021-06

Locations