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Coronary DiseaseNCT04580017

Prognostic Accuracy of the HEART Score in Undifferentiated Chest Pain: A Multicenter Validation Study

An observational study of Coronary Disease and Coronary Syndrome, run by University of Monastir at 3 sites in Tunisia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 years and olderHealthy volunteers can take part
How many people
4,267 participants
Where
3 sitesTunisia
Study dates
Jan 2015to Aug 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

Tunisia3 sites
  • Sahloul University Hospital

    Hammam Sousse, Sousse Governorate, 4011

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

    Monastir, 5000

  • Emergency department of university hospital Farhad Hached, Sousse

    Sousse, 4000

Other trials in Tunisia

About this study

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.

Read more

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.

Read the detailed description

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. Obviously, medical history, clinical examination, and laboratory values may help to identify patients with true ACS. None are sufficiently accurate to be used independently. Thus, about 5% of ACS patients are inappropriately discharged annually. Therefore, there is a global tendency for ED physician to overinvestigate chest pain patients with further, often more invasive testing, even in low-risk patients. This kind of practice leads to resource overutilization and a huge health costs waste contrasting with no outcomes improvement.

For many years, physicians were searching tools, ranging from specific diagnostic tests to entire strategies of evaluation, to appropriately risk stratify patients with chest pain in order to simultaneously prevent major adverse cardiac events and reduce unnecessary testing and hospitalisations. Based on the principal that a prompt quick and accurate identification of patients who are at high and low risk of developing major adverse cardiac events is paramount, and in order to optimally allocate ED and hospital resources, many bioclinical scores have been developed. One of the most known risk scores is TIMI score, which was originally derived and validated in a population of in-patients with unstable angina and non ST elevation myocardial infarction (NSTEMI). Its main performance is to predict early occurrence of major cardiovascular events (MACE). However, TIMI score like many other specific scores gave conflicting results when applied on chest pain patients in the ED. 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. A recent systematic review comprehensively compared the leading clinical prediction rules for chest pain, including the TIMI, the HEART, and the GRACE scores. Among the three risk stratification tools, the HEART score was found to be the most useful for managing patients with undifferentiated chest pain who present to the ED because it is simple, easy, and quick to use and it also has been validated in several studies conducted in the ED. Additional studies providing further worldwide data about the validation of this risk score will empower emergency physicians' decision making when relying on this score in ruling in or ruling out their chest pain patients. 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.

Medical subject headings
Coronary Disease, Angina, Unstable

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mace

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

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2020
  2. Study startJan 2015
  3. Primary completionApr 2017
  4. Study completionAug 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
4,267 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04580017
Sponsor's protocol ID
HEART score
Status last verified
Apr 2021
First submitted
29 Sep 2020
Last updated
7 Jul 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Disease and Coronary Syndrome, run by University of Monastir at 3 sites in Tunisia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mace (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.

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