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

Hospital Samaritano Paulista

Status: Completed

Conditions: Acute Coronary Syndrome; Chest Pain

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04756362

001/20

Details and patient eligibility

About

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

Full 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.

Enrollment: 5,497 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

5,497 participants in 2 patient groups

Prospective cohort

Description:

A minimum of 294 patients will be included in the evaluation of 0 and 1 hour protocol (prospective evaluation).

Retrospective cohort

Description:

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).