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Rapid safe approach to determining which patients who present to the Emergency Department with chest pain of a possible cardiac origin may be safely discharged.

A PRAGMATIC (Prospective Rapid Assessment, Gestalt, Markers Accelerated Trial In Chest pain) accelerated diagnostic protocol for the identification of low risk of adverse short-term outcome in patients who present to the Emergency Department with chest pain.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12614000417684
Acronym
PRAGMATIC
Enrollment
400
Registered
2014-04-16
Start date
2013-08-02
Completion date
Unknown
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

Determine the safety/efficacy of a locally developed accelerated diagnostic protocol for identifying "non-high risk" status for adverse outcome at up to thirty days in patients who present to the ED with chest pain. Candidates who are not obviously ST elevation myocardial infarction (STEMI) or otherwise have an ischemic ECG but no immediately apparent non-ACS cause for chest pain are prospectively enrolled and followed up up at thirty days. Major points of difference are, 1. Ability to safely dichotomize patients as either high risk or non-high risk. 2. no requirement for a formalized risk score 3. mandates early senior ED physician assessment for risk of ACS 4. very early rule out (,4 hrs) based on High Sensitivity Troponin -T (Roche) values and or delta.

Interventions

Observational. Prospective recruitment of patients identified by our protocol as non- high risk are followed up at thirty days from their index presentation to the Emergency Department (ED). Patients are eligible for the protocol if they have chest pain, a non-diagnostic electro-cardio-gram (ECG) and no immediate non-cardiac cause. Based on the clinical presentation a Senior ED Physician assesses the pre-test risk for a thirty day event. High sensitivity cardiac troponin T is taken as close t

Observational. Prospective recruitment of patients identified by our protocol as non- high risk are followed up at thirty days from their index presentation to the Emergency Department (ED). Patients are eligible for the protocol if they have chest pain, a non-diagnostic electro-cardio-gram (ECG) and no immediate non-cardiac cause. Based on the clinical presentation a Senior ED Physician assesses the pre-test risk for a thirty day event. High sensitivity cardiac troponin T is taken as close to arrival time as possible with a second troponin at two hours, based on serial clinical observation ECG and High sensitivity troponin testing a post test judgement of high or non-high risk is made by a senior ED physician. An initial troponin T of <14ngm/l with a two hour delta of 5 or less is non-high risk, an initial troponin of between 14 and 52ngm/l with a delta of <5ngm/l equals non-high risk a value >52ngm/l equals high risk. Senior physician gestalt trumps the protocol.

Sponsors

Andrew Munro
Lead SponsorIndividual

Eligibility

Sex/Gender
All
Age
25 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patients who present to the ED with chest pain of possible Acute coronary syndrome (ACS) origin with non-diagnostic ECG and no immediately obvious other cause.

Exclusion criteria

Dementia/mental illness/cognitively impaired Presentation for chest pain <30 days Refusal to consent

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026