NCT05416112

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.

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
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2022

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

June 1, 2022

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

June 8, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 13, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

May 16, 2023

Status Verified

May 1, 2023

Enrollment Period

12 months

First QC Date

June 8, 2022

Last Update Submit

May 13, 2023

Conditions

Chest Pain

Keywords

chest pain,myocardial ischemia,acute myocardial dysfunction,plethysmography,non invasive dp/dt.

Outcome Measures

Primary Outcomes (2)

  • MACE

    the occurrence of a major cardiovascular event (MACE)

    one month

  • MACE

    : the occurrence of a major cardiovascular event (MACE)

    SIX MONTHS

Eligibility Criteria

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

patients presenting to the emergency department with acute chest pain

You may qualify if:

  • age over 18 years old,
  • acute chest pain

You may not qualify if:

  • traumatic chest pain,
  • hemodynamic instability;
  • arrhythmias;
  • holders of a pacemaker;
  • STEMI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emergency Departement

Monastir, 5000, Tunisia

RECRUITING

MeSH Terms

Conditions

Chest PainMyocardial Ischemia

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Nouira Semir, professor

    Monastir University Hospital, Monastir, Tunisia, 5000

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nouira Semir, professor

CONTACT

73106046semir.nouira@rns.tn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
8 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PROFESSOR

Study Record Dates

First Submitted

June 8, 2022

First Posted

June 13, 2022

Study Start

June 1, 2022

Primary Completion

May 31, 2023

Study Completion

September 30, 2023

Last Updated

May 16, 2023

Record last verified: 2023-05

Locations

TU(1)