The safety and efficacy of implementing the PreHEART decision support tool by the Emergency Medical Service for patients with undifferentiated chest pain: a prospective randomized open blinded end-point study (PreHeart-3 study)

Completed

• Conditions: Acute coronary syndromeNon-st segment Elevated Myocardial InfarctionUndifferentiated chest pain

• Registration Number: NL-OMON27238
• Lead Sponsor: none

Brief Summary

PreHEART development and validation study has been submitted

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 5150

Inclusion Criteria

Adults with undifferentiated chest pain.

Exclusion Criteria

Communication barrier (e.g. language, understanding)
ST-segment elevation (electrocardiogram on scene is standard workup)
Any obvious etiology for the symptoms requiring direct treatment (e.g. trauma)
Being previously evaluated by ambulance personnel for the same complaint (already considered for participation)
High clinical suspicion of a life-threating condition (e.g. sudden death survivor, hypothermia, shock, aortic dissection, hypoxia or intoxication)
Cognitive impairment
End-stage renal disease
Pregnancy
Inability or unwillingness to provide informed consent
Not registered with a GP (huisarts)
COVID suspicion

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
nexpected Serious Adverse Events (USAE) at 3 and 30 days from the index contact.

Secondary Outcome Measures

Name	Time	Method
* USAE at 6 months and 1 year from the index contact<br>* Unexpected Major Adverse Cardiac Event (UMACE) at 3 days, 30 days, 6 months and 1 year after index contact. <br>* Cumulative healthcare-related costs/resource <br>* Quality of life at 3 days, 30 days, 6 months and 1 year of the index contact evaluated through the EuroQol 5D-5D-5L <br>