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

NCT ID: NCT04756362

Last Updated: 2022-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

5497 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-23

Study Completion Date

2022-07-31

Brief Summary

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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

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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.

Conditions

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Chest Pain Acute Coronary Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Prospective cohort

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

No interventions assigned to this group

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).

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Roche Diagnostics GmbH

INDUSTRY

Sponsor Role collaborator

Hospital Samaritano Paulista

OTHER

Sponsor Role lead

Responsible Party

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Pedro Gabriel Melo de Barros e Silva

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital Samaritano Paulista

São Paulo, , Brazil

Site Status

Countries

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Brazil

References

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de Barros E Silva PGM, Ferreira AA, Malafaia F, Tavares Reis AFM, Sznejder H, Lopes Junior ACA, Agostinho CA, Fonseca LHO, Okitoi DVD, Correa CM, Zincone E, Cury MP, Rosa GAL, Ribeiro HB, Soeiro AM, de Oliveira CAL, Kuusberg GC, Ohe LN, Souza DO, Manfredi AB, Martins AF, Sampaio PPN, Vaz TB, Franco LF, Ferreira CEDS, Lopes RD; IN-HOPE Investigators. Potential performance of a 0 h/1 h algorithm and a single cut-off measure of high-sensitivity troponin T in a diverse population: main results of the IN-HOPE study. Eur Heart J Acute Cardiovasc Care. 2023 Nov 16;12(11):755-764. doi: 10.1093/ehjacc/zuad082.

Reference Type DERIVED
PMID: 37450613 (View on PubMed)

Other Identifiers

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001/20

Identifier Type: -

Identifier Source: org_study_id

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