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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)

The PreHEART3 study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON27238
Enrollment
5150
Registered
2019-07-12
Start date
2020-04-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute coronary syndrome Non-st segment Elevated Myocardial Infarction Undifferentiated chest pain

Interventions

The PreHEART is available to a randomized patient whose risk of an ACS has been assessed. The decision to convey can be guided by the preHEART score which suggestion to non-convey for patients with a

Sponsors

none
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adults with undifferentiated chest pain.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Unexpected Serious Adverse Events (USAE) at 3 and 30 days from the index contact.

Secondary

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

Contacts

Public ContactDennis Sagel

UMC Groningen

d.c.sagel@umcg.nl0503616161

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)