NCT04333381

Brief Summary

The hypothesis is that an educational program aimed at emergency nurses and the implementation of measures at the organizational level reduce the time between arrival at the emergency room and the opening of the artery or balloon by 40% in patients attending for acute myocardial infarction.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 3, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

April 3, 2020

Status Verified

April 1, 2020

Enrollment Period

3 years

First QC Date

March 24, 2020

Last Update Submit

April 1, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Door-to-balloon time (D2B)

    The time between arrival at the emergency room (ER) and balloon time (D2B) in STEMI

    up to 30 days; From the arrival at the emergency room to the balloon time up to discharge

Secondary Outcomes (1)

  • ER arrival-ECG time

    up to 30 days; from the arrival at the emergency department to the ECG realization up to discharge

Study Arms (2)

Common Practice

ACTIVE COMPARATOR

Patients included in the phase I will receive common practice.

Other: Common Practice

Educational and organizational measures

EXPERIMENTAL

Patients included in the phase II will be attended by emergency nurses that received the educational and organizational intervention.

Other: Educational and organizational intervention

Interventions

Patients included after a systematic educational and organizational intervention for early diagnosis and care in myocardial infarction, aimed at emergency nurses of a tertiary Hospital capable in primary PCI. 1. The educational intervention will consist: Systematized educational intervention on acute myocardial infarction for emergency triage nurses will consist of theoretical and practical training through case presentations and clinical simulation. 2. The organizational intervention will consist: * Development and dissemination of an early diagnostic tool for acute myocardial infarction: STEMI infographics. It will be provided to all emergency nurses and emergency triage boxes * Update the STEMI hospital protocol and adapt it to the current clinical guidelines of the European Society of Cardiology (ESC) * Review organizational strategies and definition of new improvement measures * Audit the delays in STEMI * Periodic multi-disciplinary update sessions

Educational and organizational measures

Common practice is based on care by emergency nurses who did not receive any systematized education of acute myocardial infarction led by interventional cardiology nurses. On the other hand, emergency management is based on Plan-Do-Study-Act methodology and in the historical sample some organizational improvement strategies did not exist or were beginning to be implemented

Common Practice

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients ≥18 years
  • Admitted to the emergency room of the same center

You may not qualify if:

  • Pregnant women
  • Patients who did not receive coronariography were excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FGS Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

RECRUITING

Related Publications (2)

  • Berga Congost G, Martinez Momblan MA, Valverde Bernal J, Marquez Lopez A, Ruiz Gabalda J, Garcia-Picart J, Puig Campmany M, Brugaletta S. Association of sex and age and delay predictors on the time of primary angioplasty activation for myocardial infarction patients in an emergency department. Heart Lung. 2023 Mar-Apr;58:6-12. doi: 10.1016/j.hrtlng.2022.10.014. Epub 2022 Nov 3.

  • Berga Congost G, Brugaletta S, Valverde Bernal J, Marquez Lopez A, Ruiz Gabalda J, Garcia-Picart J, Puig Campmany M, Martinez Momblan MA. The importance of organizational variables in treatment time for patients with ST-elevation acute myocardial infarction improve delays in STEMI. Australas Emerg Care. 2021 Jun;24(2):141-146. doi: 10.1016/j.auec.2020.10.001. Epub 2020 Nov 14.

MeSH Terms

Conditions

ST Elevation Myocardial InfarctionMyocardial InfarctionEmergencies

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisDisease Attributes

Central Study Contacts

Gemma Berga Congost, RN, MSc, PhD student

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Quasi-experimental design study, pre-post intervention type
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2020

First Posted

April 3, 2020

Study Start

July 1, 2019

Primary Completion

July 1, 2022

Study Completion

December 31, 2022

Last Updated

April 3, 2020

Record last verified: 2020-04

Locations