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

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)

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

Study Overview

• Status: Completed
• Conditions: Chest Pain; Acute Coronary Syndrome

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 5497

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil
    • Hospital Samaritano Paulista

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients with suspected acute coronary syndrome

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Prospective cohort; A minimum of 294 patients will be included in the evaluation of 0 and 1 hour protocol (prospective evaluation).
Retrospective cohort; A minimum of 1,000 patients will be included in the evaluation of prognostic value of high sensitive cardiac troponin < 5 ng/L(retrospective evaluation).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Hospital Samaritano Paulista
• Collaborators: Roche Diagnostics

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2020
• Primary Completion (Actual): January 31, 2022
• Study Completion (Actual): July 31, 2022

Study Registration Dates

• First Submitted: February 8, 2021
• First Submitted That Met QC Criteria: February 11, 2021
• First Posted (Actual): February 16, 2021

Study Record Updates

• Last Update Posted (Actual): August 3, 2022
• Last Update Submitted That Met QC Criteria: August 1, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Acute coronary syndrome; Chest pain; Troponin
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Chest Pain; Acute Coronary Syndrome
• Other Study ID Numbers: 001/20

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No