A Comparison of the TIMI, GRACE, HEART and HEARTSIL Scores

Sponsor
Konya Meram State Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04661722
Collaborator
(none)
600
1
5.2
114.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: No intervention

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

Study Type:
Observational
Anticipated Enrollment :
600 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Comparison of Prognostic Performance of TIMI, GRACE, HEART and HEARTSIL SCORES in Patients Admitted to the Emergency Department With Chest Pain
Actual Study Start Date :
Feb 5, 2021
Anticipated Primary Completion Date :
Jun 14, 2021
Anticipated Study Completion Date :
Jul 14, 2021

Outcome Measures

Primary Outcome Measures

  1. Major Adverse Cardiac Events (MACE) at 30 days [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.

Secondary Outcome Measures

  1. Major Adverse Cardiac Events (MACE) at 3 days [3 days after presentation.]

    The primary outcome is MACE at 3 days. MACE is a composite outcome of cardiac death, acute myocardial infarction, and coronary revascularization.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Konya City Hospital Konya Turkey 42020

Sponsors and Collaborators

  • Konya Meram State Hospital

Investigators

  • Principal Investigator: Nazire B Akilli, Assoc Prof, Konya City Hospital
  • Study Chair: Pervin Sagdıc, MD, Konya City Hospital
  • Study Chair: Turgut Uygun, MD, Konya City Hospital
  • Study Chair: Ramazan Koylu, Assoc Prof, Konya City Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nazire B Akilli,MD, associate professor, Konya Meram State Hospital
ClinicalTrials.gov Identifier:
NCT04661722
Other Study ID Numbers:
  • Konya city hospital
First Posted:
Dec 10, 2020
Last Update Posted:
Apr 26, 2021
Last Verified:
Dec 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 26, 2021