NCT04756362

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,497

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 23, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 16, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
Last Updated

August 3, 2022

Status Verified

August 1, 2022

Enrollment Period

1.5 years

First QC Date

February 8, 2021

Last Update Submit

August 1, 2022

Conditions

Chest PainAcute Coronary Syndrome

Keywords

Chest painAcute coronary syndromeTroponin

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

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

    30 days

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

    30 days

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

    30 days

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

    30 days

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

    30 days

  • +1 more secondary outcomes

Study Arms (2)

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).

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive patients with suspected acute coronary syndrome

You may qualify if:

  • Age ≥ 18 years of age
  • The patient agrees and signs an informed consent form
  • One of the following 2 criteria:

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Samaritano Paulista

São Paulo, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 37450613DERIVED

MeSH Terms

Conditions

Chest PainAcute Coronary Syndrome

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 8, 2021

First Posted

February 16, 2021

Study Start

July 23, 2020

Primary Completion

January 31, 2022

Study Completion

July 31, 2022

Last Updated

August 3, 2022

Record last verified: 2022-08

Locations

BR(1)