Chest PainNCT04661722
A Comparison of the TIMI, GRACE, HEART and HEARTSIL Scores
An observational study of Chest Pain, run by Konya Meram State Hospital at 1 site in Turkey (Türkiye).
Trial summary
Chest pain is one of the most common reasons for emergency admission. Chest pain can be caused by many cardiac and noncardiac causes. Acute Coronary Syndrome (ACS) is one of the most im-portant of these etiologies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chest Pain
- How many people
- 600 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Feb 2021to 14 Jul 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chest pain.
Who may be able to join
- Patient presenting to the emergency department with chest pain
Who cannot join
- ST elevation myocardial infarction,
- Pneumonia, pneumothorax, pulmonary embolism and esophageal rupture
- Patients under 18 years of age
- Pregnant patients
- Patients who do not want to be included in the study
Trial locations and contacts
1 site in 1 country.
Pervin Sagdıc, MD contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Konya City Hospital
Konya, 42020
Mehmet A Eryılmaz, Asoc prof, +90 332 310 50 00
About this study
Official title: Comparison of Prognostic Performance of TIMI, GRACE, HEART and HEARTSIL SCORES in Patients Admitted to the Emergency Department With Chest Pain
Chest pain is one of the most common reasons for emergency admission. Chest pain can be caused by many cardiac and noncardiac causes. Acute Coronary Syndrome (ACS) is one of the most im-portant of these etiologies. ACS has a high mortality rate, but with early diagnosis and related inter-ventions, a high rate of prognosis can be improved. Therefore, early recognition of AKS is impor-tant. However, the challenge in emergency services is not only to identify patients with high risk for ACS. Early detection of low-risk patients is also important for emergency room management. These patients should be discharged quickly with minimal examination and treatment. The follow-up of these patients with the acceptance of ACS brings along unnecessary examinations and treatments. This leads to an increase in healthcare costs and an increase in crowd in emergency services and hospitals.
Evaluation of chest pain in the emergency room and early detection of life-threatening conditions such as ACS present many difficulties for clinicians. For this reason, clinicians use some scoring systems that determine the risk stratification of patients and the probability of having acute coronary syndrome. Heart score is one of the scores developed for this purpose. However vital signs are not included in calculating the heart score. Therefore, the investigators considered to include the shock index calcula-ted by systolic blood pressure and pulse in this scoring system. In addition, the investigators have included a very valuable biochemical parameter such as lactate that predicts mortality in many diseases in this scoring system. The investigators named this scoring system HEARTSIL. The investigators aim to compare the diagnostic performance of this score with the diagnostic performance of other scoring systems.
Read the detailed description
The study was planned to be conducted in Konya City Hospital Emergency Service. Adult patients over 18 years of age who present to the emergency department with chest pain will be included in the study. Patients who do not consent to participate in the study due to chest pain such as ST elevation myocardial infarction, pneumonia, pneumothorax, pulmonary embolism and esophageal rupture will be excluded from the study. Vital signs of the patients, background information, the nature of the pain, the drugs used will be recorded. Blood tests and electrocardiogram will be recorded. Heart Score, TIMI, GRACE score will be calculated. Shock index and lactate value will also be included in the heart score. Shock index 0.5-0.7 = 0 points, 0.71-1 = 1 point and above 1 will be cal-culated as 2 points. Lactate levels 0-2 mEq/L =0 points, between 2,1-3,99 mEq/L= 1 point, above 4 mEq/L levels will be calculated 2 points. These points will be added to the Heart Score and will be named HEARTSIL. Patients will be followed in terms of major cardiac events (MACE) for 3 days and 1 month. Prog-nostic performance of HEARTSIL Score, Heart Score, GRACE, TIMI scores that the investigators developed will be compared.
The data will be uploaded to the database for statistics. First of all, whether the data is normally distributed or not will be determined. Student-t for normally distributed data, Mann-witney-u test for data that are not normally distributed, and chi-square will be used for comparing categorical data. The ROC curve will be drawn and compared in determining the prognostic performance of scoring systems for MACE development. In addition, PPD, NPD, +LR and -LR sensitivity and spe-cificities will be calculated. Values with a p value below 0.05 will be considered statistically signifi-cant.
- Conditions
- Chest Pain
- Being tested
- No intervention
- Medical subject headings
- Chest Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiac Events (MACE) at 30 days
The primary outcome is MACE at 30 days. MACE is a composite outcome of cardiac death, acute myocardial infarction, and coronary revascularization.
Measured: 30 days after presentation.
Secondary outcomes (1)
Major Adverse Cardiac Events (MACE) at 3 days
The primary outcome is MACE at 3 days. MACE is a composite outcome of cardiac death, acute myocardial infarction, and coronary revascularization.
Measured: 3 days after presentation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start5 Feb 2021
- Primary completion14 Jun 2021 (estimated)
- Study completion14 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chest PainStudies 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
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Konya Meram State Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nazire B Akilli,MD, Konya Meram State Hospital
- Investigators
- Nazire B Akilli, Assoc Prof, Principal investigator, Konya City HospitalPervin Sagdıc, MD, Study chair, Konya City HospitalTurgut Uygun, MD, Study chair, Konya City HospitalRamazan Koylu, Assoc Prof, Study chair, Konya City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04661722
- Sponsor's protocol ID
- Konya city hospital
- Status last verified
- Dec 2020
- First submitted
- 3 Dec 2020
- Last updated
- 26 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Prognostic Performance of TIMI, GRACE, HEART and HEARTSIL SCORES in Patients Admitted to the Emergency Department With Chest Pain
- ClinicalTrials.gov ID
- NCT04661722
- Acronym / sponsor ID
- Konya city hospital
- Conditions
- Chest Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Konya Meram State HospitalUniversity, hospital or other
- Study start
- 5 Feb 2021 (actual)
- Primary completion
- 14 Jun 2021 (estimated)
- Study completion
- 14 Jul 2021 (estimated)
- First posted
- 10 Dec 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 is one of the most common reasons for emergency admission. Chest pain can be caused by many cardiac and noncardiac causes. Acute Coronary Syndrome (ACS) is one of the most im-portant of these etiologies. ACS has a high mortality rate, but with early diagnosis and related inter-ventions, a high rate of prognosis can be improved. Therefore, early recognition of AKS is impor-tant. However, the challenge in emergency services is not only to identify patients with high risk for ACS. Early detection of low-risk patients is also important for emergency room management. These patients should be discharged quickly with minimal examination and treatment. The follow-up of these patients with the acceptance of ACS brings along unnecessary examinations and treatments. This leads to an increase in healthcare costs and an increase in crowd in emergency services and hospitals.
Evaluation of chest pain in the emergency room and early detection of life-threatening conditions such as ACS present many difficulties for clinicians. For this reason, clinicians use some scoring systems that determine the risk stratification of patients and the probability of having acute coronary syndrome. Heart score is one of the scores developed for this purpose. However vital signs are not included in calculating the heart score. Therefore, the investigators considered to include the shock index calcula-ted by systolic blood pressure and pulse in this scoring system. In addition, the investigators have included a very valuable biochemical parameter such as lactate that predicts mortality in many diseases in this scoring system. The investigators named this scoring system HEARTSIL. The investigators aim to compare the diagnostic performance of this score with the diagnostic performance of other scoring systems.
Detailed description
The study was planned to be conducted in Konya City Hospital Emergency Service. Adult patients over 18 years of age who present to the emergency department with chest pain will be included in the study. Patients who do not consent to participate in the study due to chest pain such as ST elevation myocardial infarction, pneumonia, pneumothorax, pulmonary embolism and esophageal rupture will be excluded from the study. Vital signs of the patients, background information, the nature of the pain, the drugs used will be recorded. Blood tests and electrocardiogram will be recorded. Heart Score, TIMI, GRACE score will be calculated. Shock index and lactate value will also be included in the heart score. Shock index 0.5-0.7 = 0 points, 0.71-1 = 1 point and above 1 will be cal-culated as 2 points. Lactate levels 0-2 mEq/L =0 points, between 2,1-3,99 mEq/L= 1 point, above 4 mEq/L levels will be calculated 2 points. These points will be added to the Heart Score and will be named HEARTSIL. Patients will be followed in terms of major cardiac events (MACE) for 3 days and 1 month. Prog-nostic performance of HEARTSIL Score, Heart Score, GRACE, TIMI scores that the investigators developed will be compared.
The data will be uploaded to the database for statistics. First of all, whether the data is normally distributed or not will be determined. Student-t for normally distributed data, Mann-witney-u test for data that are not normally distributed, and chi-square will be used for comparing categorical data. The ROC curve will be drawn and compared in determining the prognostic performance of scoring systems for MACE development. In addition, PPD, NPD, +LR and -LR sensitivity and spe-cificities will be calculated. Values with a p value below 0.05 will be considered statistically signifi-cant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chest pain.
Key inclusion criteria (1 listed)
- Patient presenting to the emergency department with chest pain
Key exclusion criteria (5 listed)
- ST elevation myocardial infarction,
- Pneumonia, pneumothorax, pulmonary embolism and esophageal rupture
- Patients under 18 years of age
- Pregnant patients
- Patients who do not want to be included in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | – |
Primary outcome
Major Adverse Cardiac Events (MACE) at 30 days
Time frame: 30 days after presentation.
The primary outcome is MACE at 30 days. MACE is a composite outcome of cardiac death, acute myocardial infarction, and coronary revascularization.
1 secondary outcome
Major Adverse Cardiac Events (MACE) at 3 days
Time frame: 3 days after presentation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2021.
- Individual participant dataSharing planned: No
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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.
Pervin Sagdıc, MD contact
Nazire B Akilli, Assoc Prof principal investigator
Konya City Hospital
Pervin Sagdıc, MD study chair
Konya City Hospital
Turgut Uygun, MD study chair
Konya City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chest Pain, run by Konya Meram State Hospital at 1 site in Turkey (Türkiye).
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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 26 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nazire Belgin Akilli, assoc prof (+90 5055377520, drbelginakilli@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiac Events (MACE) at 30 days (time frame: 30 days after presentation.). 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 26 Apr 2021.