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Completed

NCT Number: NCT04756362

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Samaritano Paulista

São Paulo, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years of age
  • The patient agrees and signs an informed consent form
  • One of the following 2 criteria:
  • Acute chest pain (last episode of pain beginning <6 hours after inclusion) or
  • 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

Treatment and study plan

Primary outcomes

  1. Accuracy of early rule out for myocardial infarction diagnosis

    Time frame: 30 days

    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

Secondary outcomes

  1. Accuracy of early rule out for myocardial infarction according to type of symptoms

    Time frame: 30 days

    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

  2. Accuracy of early rule out for myocardial infarction according to chest pain score (TIMI)

    Time frame: 30 days

    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).

  3. Accuracy of early rule out for myocardial infarction according to chest pain score (EDACS)

    Time frame: 30 days

    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).

  4. Accuracy of early rule out for myocardial infarction according to chest pain score (GRACE)

    Time frame: 30 days

    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).

  5. Accuracy of early rule out for myocardial infarction according to chest pain score (HEART)

    Time frame: 30 days

    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).

  6. 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.

    Time frame: 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 (retrospective cohort).

Sponsors and collaborators

Lead sponsor

Hospital Samaritano Paulista

Other

Collaborators

  • Roche Diagnostics GmbH

Registry information

Official study 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)

Acronym: In-Hope

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Feb 16, 2021
Registry last updated
Aug 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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