IN-HOspital Program to systematizE Chest Pain Protocol (IN-HOPE)

Acute Coronary Syndrome Clinical Trial

— In-Hope  

Official title:

Potential Impact in Clinical Practice of Early Exclusion Protocols for Acute Myocardial Infarction With High Sensitivity Troponin T in Different Scenarios (IN-HOspital Program to SystematizE Chest Pain Protocol-IN HOPE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04756362
• Other study ID #: 001/20
• Status: Completed
• Start date: July 23, 2020
• Est. completion date: July 31, 2022

Study information

• Verified date: August 2022
• Source: Hospital Samaritano Paulista
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Multicenter Nationwide Study for Analysis of the Potential Impact in Clinical Practice of Early Exclusion Protocols for Acute Myocardial Infarction with High Sensitivity Troponin T

Description:

Chest pain is the main clinical complaint in emergency room visits and represents the most common symptom of Acute Myocardial Infarction, which is the main cause of death in Brazil and worldwide. Although most patients with chest pain do not have a final diagnosis of AMI, they remain under observation until the diagnosis of AMI is excluded. The most current strategy recommended for rapid AMI exclusion uses high-sensitivity cardiac troponin T at time zero and one hour later. However, some points that have not yet been properly evaluated in previous studies can be evaluated in the current study:

• Evaluation of the early exclusion protocol (0 -1 hour) in a Brazilian population

• Evaluation of the early exclusion protocol (0 -1 hour) in isolation and associated with traditional risk scores (TIMI, GRACE, HEART and EDACS)

• Systematic evaluation of the early exclusion protocol (0 -1 hour) in patients without chest pain but with a pre-defined condition of suspected AMI

• Evaluation of the prognostic value of an isolated high-sensitivity cardiac troponin T < 5 ng/L in a diverse population.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5497
• Est. completion date: July 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years of age

• The patient agrees and signs an informed consent form

• One of the following 2 criteria:

1. Acute chest pain (last episode of pain beginning <6 hours after inclusion) or

2. Syncope, dyspnea or epigastric pain without an obvious cause at the initial assessment (last episode of one of these symptoms beginning <6 hours after inclusion) associated with at least one of the following factors: Age = 65 years, history of arterial disease, history of diabetes mellitus.

Exclusion Criteria:

• Cardiac arrest or hypoxemia or hemodynamic instability or cardioversion during the first hour of assessment

• Thrombolytic therapy, primary angioplasty or other medical condition that requires hospitalization identified within one hour after the evaluation

• Dialysis patients

• Patients with trauma

• Myocardial revascularization or acute myocardial infarction in the last month

• Pregnant and breastfeeding women

• Patient unable to be followed for 30 days

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Chest Pain

Locations

Country	Name	City	State
Brazil	Hospital Samaritano Paulista	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Samaritano Paulista	Roche Diagnostics

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of early rule out for myocardial infarction diagnosis	Accuracy of the 0 and 1 hour algorithm using troponin for diagnosis of myocardial infarction compared to the gold standard with measurements every 3 hours	30 days
Secondary	Accuracy of early rule out for myocardial infarction according to type of symptoms	Accuracy of the 0 and 1 hour algorithm using troponin for diagnosis of myocardial infarction compared to the gold standard with measurements every 3 hours with or without chest pain	30 days
Secondary	Accuracy of early rule out for myocardial infarction according to chest pain score (TIMI)	Accuracy of the 0 and 1 hour algorithm using troponin for diagnosis of myocardial infarction compared to the gold standard with measurements every 3 hours according to chest pain score (TIMI). TIMI score minimum 0 and maximum 7 points (higher scores mean a worse outcome).	30 days
Secondary	Accuracy of early rule out for myocardial infarction according to chest pain score (EDACS)	Accuracy of the 0 and 1 hour algorithm using troponin for diagnosis of myocardial infarction compared to the gold standard with measurements every 3 hours according to chest pain score (EDACS). EDACS score minimum -6 and maximum +20 points (higher scores mean a worse outcome).	30 days
Secondary	Accuracy of early rule out for myocardial infarction according to chest pain score (GRACE)	Accuracy of the 0 and 1 hour algorithm using troponin for diagnosis of myocardial infarction compared to the gold standard with measurements every 3 hours according to chest pain score (GRACE). GRACE score minimum 1 and maximum 372 points (higher scores mean a worse outcome).	30 days
Secondary	Accuracy of early rule out for myocardial infarction according to chest pain score (HEART)	Accuracy of the 0 and 1 hour algorithm using troponin for diagnosis of myocardial infarction compared to the gold standard with measurements every 3 hours according to chest pain score (HEART). HEART score minimum 0 and maximum 10 points (higher scores mean a worse outcome).	30 days
Secondary	Evaluation of the prognostic value (death and myocardial infarction within 30 days) of an isolated high-sensitivity cardiac troponin T < 5 ng/L in a diverse population.	Evaluation of the prognostic value (death and myocardial infarction within 30 days) of an isolated high-sensitivity cardiac troponin T < 5 ng/L in a diverse population (retrospective cohort).	30 days