NCT04661722

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 10, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

February 5, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 14, 2021

Completed
Last Updated

April 26, 2021

Status Verified

December 1, 2020

Enrollment Period

4 months

First QC Date

December 3, 2020

Last Update Submit

April 22, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    30 days after presentation.

Secondary Outcomes (1)

  • Major Adverse Cardiac Events (MACE) at 3 days

    3 days after presentation.

Interventions

No intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with chest pain.

You may qualify if:

  • Patient presenting to the emergency department with chest pain

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Konya City Hospital

Konya, 42020, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Chest Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Nazire B Akilli, Assoc Prof

    Konya City Hospital

    PRINCIPAL INVESTIGATOR
  • Pervin Sagdıc, MD

    Konya City Hospital

    STUDY CHAIR
  • Turgut Uygun, MD

    Konya City Hospital

    STUDY CHAIR
  • Ramazan Koylu, Assoc Prof

    Konya City Hospital

    STUDY CHAIR

Central Study Contacts

Nazire Belgin Akilli, assoc prof

CONTACT

Pervin Sagdıc, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

December 3, 2020

First Posted

December 10, 2020

Study Start

February 5, 2021

Primary Completion

June 14, 2021

Study Completion

July 14, 2021

Last Updated

April 26, 2021

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations