Clinical trial NCT04661722: A Comparison of the TIMI, GRACE, HEART and HEARTSIL Scores
Official title: Comparison of Prognostic Performance of TIMI, GRACE, HEART and HEARTSIL SCORES in Patients Admitted to the Emergency Department With Chest Pain
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chest Pain
Lead sponsor: Konya Meram State Hospital
Sponsor class: OTHER
First posted: 2020-12-10
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with chest pain.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Patient presenting to the emergency department with chest pain

Exclusion Criteria:

* 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

Primary outcomes:
measure: Major Adverse Cardiac Events (MACE) at 30 days
timeFrame: 30 days after presentation.
Secondary outcomes:
measure: Major Adverse Cardiac Events (MACE) at 3 days
timeFrame: 3 days after presentation.
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Konya City Hospital
Study officials:
affiliation: Konya City Hospital
name: Nazire B Akilli, Assoc Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Konya City Hospital
name: Pervin Sagdıc, MD
role: STUDY_CHAIR
affiliation: Konya City Hospital
name: Turgut Uygun, MD
role: STUDY_CHAIR
affiliation: Konya City Hospital
name: Ramazan Koylu, Assoc Prof
role: STUDY_CHAIR
References: