Clinical trial NCT04756362: IN-HOspital Program to systematizE Chest Pain Protocol (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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chest Pain
Acute Coronary Syndrome
Keywords: Chest pain
Acute coronary syndrome
Troponin
Lead sponsor: Hospital Samaritano Paulista
Sponsor class: OTHER
Collaborators: name: Roche Diagnostics GmbH
First posted: 2021-02-16
Enrollment: 5497
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients with suspected acute coronary syndrome

Brief 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Accuracy of early rule out for myocardial infarction diagnosis
timeFrame: 30 days
Secondary outcomes:
measure: Accuracy of early rule out for myocardial infarction according to type of symptoms
timeFrame: 30 days
measure: Accuracy of early rule out for myocardial infarction according to chest pain score (TIMI)
timeFrame: 30 days
measure: Accuracy of early rule out for myocardial infarction according to chest pain score (EDACS)
timeFrame: 30 days
measure: Accuracy of early rule out for myocardial infarction according to chest pain score (GRACE)
timeFrame: 30 days
measure: Accuracy of early rule out for myocardial infarction according to chest pain score (HEART)
timeFrame: 30 days
measure: 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.
timeFrame: 30 days
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital Samaritano Paulista
Study officials:
References: