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Non-invasive Left Ventricle Contractility dp/dt as Prognostic Marker in Chest Unit Patients

Sponsor
University of Monastir (Other)
Overall Status
Recruiting
CT.gov ID
NCT05416112
Collaborator
(none)
500
Enrollment
1
Location
8
Anticipated Duration (Months)
62.4
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Detailed 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.

    We 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.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Non Invasive Left Ventricle Contractility dp/dt Could be Used as a Prognostic Marker in Patients Admitted to the Emergency Department for Chest Pain
    Actual Study Start Date :
    Jun 1, 2022
    Anticipated Primary Completion Date :
    Jul 31, 2022
    Anticipated Study Completion Date :
    Jan 31, 2023

    Outcome Measures

    Primary Outcome Measures

    1. MACE [one month]

      the occurrence of a major cardiovascular event (MACE)

    2. MACE [SIX MONTHS]

      : the occurrence of a major cardiovascular event (MACE)

    Eligibility Criteria

    Criteria

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

    • age over 18 years old,

    • acute chest pain

    Exclusion criteria:

    • traumatic chest pain,

    • hemodynamic instability;

    • arrhythmias;

    • holders of a pacemaker;

    • STEMI

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Emergency Departement Monastir Tunisia 5000

    Sponsors and Collaborators

    • University of Monastir

    Investigators

    • Principal Investigator: Nouira Semir, professor, Monastir University Hospital, Monastir, Tunisia, 5000

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Pr. Semir Nouira, PROFESSOR, University of Monastir
    ClinicalTrials.gov Identifier:
    NCT05416112
    Other Study ID Numbers:
    • dp/dt
    First Posted:
    Jun 13, 2022
    Last Update Posted:
    Jun 13, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Pr. Semir Nouira, PROFESSOR, University of Monastir
    chest pain,
    myocardial ischemia,
    acute myocardial dysfunction,
    plethysmography,
    non invasive dp/dt.
    Additional relevant MeSH terms:
    Chest Pain

    Study Results

    No Results Posted as of Jun 13, 2022