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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05416112
Other study ID # dp/dt
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 1, 2022
Est. completion date September 30, 2023

Study information

Verified date May 2023
Source University of Monastir
Contact Nouira Semir, professor
Phone 73106046
Email semir.nouira@rns.tn
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Ischemic heart disease is a major public health problem with high mortality rate despite the progress in management and the resources mobilized. The idea is that myocardial ischemia is generally associated with left ventricular dysfunction and, consequently, a possible alteration of the dp/dt index. As dp/dt could be assessed non-invasively by plethysmographic method, it is interesting to investigate its prognostic performance in patients with indifferentiate chest pain.


Description:

Ischemic heart disease remains a major public health problem. Despite all the advances in the prognostic approach to ischemic heart disease, the risk of occurrence of major cardiovascular events is not negligible. Several scores have been proposed for chest pain stratification risk, the most widely used are the TIMI and the GRACE scores. The dP/dt max is therefore an excellent index of contractility, corresponding to the maximum level of tension developed by an isolated cardiac muscle during the isovolumic contraction phase. the investigator theorized that a less value of dp/dt would be associated with more major cardiovascular events (MACE), because ischemia reduces myocardial contractility. The current study describes non-invasive plethysmographic dp/dt changes, which could be used as a prognostic marker in patients presenting at the emergency department with acute chest pain.


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date September 30, 2023
Est. primary completion date May 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria: - age over 18 years old, - acute chest pain Exclusion criteria: - traumatic chest pain, - hemodynamic instability; - arrhythmias; - holders of a pacemaker; - STEMI

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Tunisia Emergency Departement Monastir

Sponsors (1)

Lead Sponsor Collaborator
University of Monastir

Country where clinical trial is conducted

Tunisia, 

Outcome

Type Measure Description Time frame Safety issue
Primary MACE the occurrence of a major cardiovascular event (MACE) one month
Primary MACE : the occurrence of a major cardiovascular event (MACE) SIX MONTHS
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