NCT04580017

Brief Summary

Chest pain remains one of the most common, potentially serious presenting complaints for adults emergency department visits with approximately 7.6 million yearly visits in the united states. The priority for emergency physician is to determine whether these patients with acute chest pain have a potential life threatening underlying etiology. The great challenge is to differentiate patients presenting with acute coronary syndrome and those with other more benign conditions. There is a global tendency for ED physician to over investigate chest pain patients , even in low-risk patients. This kind of practice leads to resource over-utilization and a huge health costs waste contrasting with no outcomes improvement. For many years, physicians have been searching tools, ranging from specific diagnostic tests to entire strategies of evaluation, to appropriately stratify the risk in patients with chest pain in order to simultaneously prevent major adverse cardiac events and reduce unnecessary testing and hospitalizations. Many bioclinical scores have been developed, such as the TIMI score and the GRACE score.The HEART score is one of the more recently proposed model derived through a process involving expert opinion and review of medical literature. It is calculated based on admission data of medical history, EKG, age, cardiovascular risk factors and troponin levels. The HEART score was created specifically to identify ED patients presenting with undifferentiated chest pain who were at low risk as well as patients at high risk of short-term MACE occurrence. HEART score has been widely reported to outperform the TIMI and the GRACE scores. Several scientific societies are encouraging the use of HEART score, for evaluating patients with chest pain suggestive of ACS in the ED. The goal of our investigation is to validate HEART score as a prognostication tool among ED patients with chest pain in teaching hospitals in Tunisia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4,267

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
completed

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

January 1, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

September 29, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 8, 2020

Completed
Last Updated

May 6, 2021

Status Verified

April 1, 2021

Enrollment Period

2.2 years

First QC Date

September 29, 2020

Last Update Submit

April 30, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Mace

    Rate of MACE occurence including all-cause mortality, non-fatal myocardial infarction (MI), and coronary revascularisation within 30 days.

    30 days

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients aged over 30 years admitted to the ED with typical chest pain with an EKG not showing STEMI.

You may qualify if:

  • Any adult aged older than 30 years.
  • Chief complaint of ''chest pain'', ''chest tightness'', or ''chest pressure''.

You may not qualify if:

  • Shortness of breath without chest pain
  • ST elevation myocardial infarction (STEMI)
  • Patients lost to follow up
  • Patients with obvious diagnosis made immediately after initial medical evaluation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Sahloul University Hospital

Hammam Sousse, Sousse Governorate, 4011, Tunisia

Location

Emergency department of university hospital Fattouma Bourguiba of Monastir Monastir, Monastir Tunisia

Monastir, 5000, Tunisia

Location

Emergency department of university hospital Farhad Hached, Sousse

Sousse, 4000, Tunisia

Location

MeSH Terms

Conditions

Coronary DiseaseAngina, Unstable

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesAngina PectorisChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Nouira semir, MD

    CHU fattouma Bourguiba Monastir

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professeur

Study Record Dates

First Submitted

September 29, 2020

First Posted

October 8, 2020

Study Start

January 1, 2015

Primary Completion

April 1, 2017

Study Completion

August 1, 2018

Last Updated

May 6, 2021

Record last verified: 2021-04

Locations