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.
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
- Conditions the study is for
- Coronary Disease, Coronary Syndrome, Risk Factor, Cardiovascular
- 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
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.
- Conditions
- Coronary Disease, Coronary Syndrome, Risk Factor, Cardiovascular, Major Adverse Cardiovascular Events
- Medical subject headings
- Coronary Disease, Angina, Unstable
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted8 Oct 2020
- Study startJan 2015
- Primary completionApr 2017
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Monastir
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr. Semir Nouira, University of Monastir
- Investigators
- Nouira semir, MD, Principal investigator, CHU fattouma Bourguiba Monastir
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
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Accuracy of the HEART Score in Undifferentiated Chest Pain: A Multicenter Validation Study
- ClinicalTrials.gov ID
- NCT04580017
- Acronym / sponsor ID
- HEART score
- Conditions
- Coronary Disease, Coronary Syndrome, Risk Factor, Cardiovascular, Major Adverse Cardiovascular Events
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,267 participants (actual)
- Lead sponsor
- University of MonastirUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 8 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged over 30 years admitted to the ED with typical chest pain with an EKG not showing STEMI.
Key inclusion criteria (2 listed)
- Any adult aged older than 30 years.
- Chief complaint of ''chest pain'', ''chest tightness'', or ''chest pressure''.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mace
Time frame: 30 days
Rate of MACE occurence including all-cause mortality, non-fatal myocardial infarction (MI), and coronary revascularisation within 30 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nouira semir, MD principal investigator
CHU fattouma Bourguiba Monastir
3 sites in 1 country: see every site and its status.
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.