Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000417684
Ethics application status
Approved
Date submitted
20/03/2014
Date registered
16/04/2014
Date last updated
16/04/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
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.
Scientific title
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.
Secondary ID [1] 284294 0
nil
Universal Trial Number (UTN)
1111-1154-7703
Trial acronym
PRAGMATIC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chest pain 291441 0
Acute Coronary Syndrome 291442 0
Condition category
Condition code
Cardiovascular 291815 291815 0 0
Coronary heart disease

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
30
Target follow-up type
Days
Description of intervention(s) / exposure
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.
Intervention code [1] 289017 0
Not applicable
Comparator / control treatment
Rule-out rule in high risk within six hours ED length of stay. Rule out requires a non diagnostic ECG and early SMO pre test probablitiy for ACS 30 day event. HS trop TR is taken at time zero and again at two hours if required. Basline tropnin < 14ng/l with delta of <5 at two hours is rule out. Mid range troponin 14-53 ng/l and delta <5 was rule out. SMO gestalt for rule in trumps the protocol.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291729 0
Combined death acute myocardial infarction (AMI )at thirty days.
Combined record review and follow -up structured telephone interview
Timepoint [1] 291729 0
Thirty days following index ED presentation
Secondary outcome [1] 307362 0
Senior ED physician pre-test and post test probability for adverse outcome. pre test probablity is obtained prior to knowledge of HS troponin result. Post test probabilty is designated by the ADP where senior ED physician determines high or non high risk for 30 day ACS/death
Timepoint [1] 307362 0
30 days following index presentation
Secondary outcome [2] 307367 0
ED length of stay
Timepoint [2] 307367 0
ED length of stay is measured as triage to discharge from ED time. Bench marked against six hour ED length of stay.

Eligibility
Key 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.
Minimum age
25 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Dementia/mental illness/cognitively impaired
Presentation for chest pain <30 days
Refusal to consent

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Power calculation based on existing prevalence -(P) (ACS minus STEMI) of 15% using existing study looking at 24 hr MACE- Parsonage et al
This study n= had a True Positive (TP)54 false negative (FN) of 2 TP +FP /P =373

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/08/2013
Actual
2/08/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment outside Australia
Country [1] 5909 0
New Zealand
State/province [1] 5909 0
Tasman

Funding & Sponsors
Funding source category [1] 288925 0
Self funded/Unfunded
Name [1] 288925 0
Country [1] 288925 0
Primary sponsor type
Individual
Name
Andrew Munro
Address
Emergency Department
Nelson Hospital
Private bag 18
Nelson 7042
NZ
Country
New Zealand
Secondary sponsor category [1] 287617 0
Individual
Name [1] 287617 0
Tom Jerram
Address [1] 287617 0
Emergency Department
Nelson Hospital
Private Bag 18
Nelson7042
NZ
Country [1] 287617 0
New Zealand
Other collaborator category [1] 277884 0
Individual
Name [1] 277884 0
Tom Morton
Address [1] 277884 0
Emergency Department
Nelson Hospital
Private Bag 18
Nelson7042
NZ
Country [1] 277884 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290752 0
Northern B HDC
Ethics committee address [1] 290752 0
HDC
Ministry Of Health
PO Box 5013
Wellington 6105
Ethics committee country [1] 290752 0
New Zealand
Date submitted for ethics approval [1] 290752 0
01/07/2013
Approval date [1] 290752 0
17/07/2013
Ethics approval number [1] 290752 0
13/NTB/72

Summary
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.
Trial website
www.chestpainstudy.wordpress.com
Trial related presentations / publications
Methodology presented at College of Emergency Nurses New Zealand 2013 see
http://www.nzno.org.nz/groups/colleges/college_of_emergency_nurses/cennz_events
Public notes

Contacts
Principal investigator
Name 47078 0
Dr Andrew Munro
Address 47078 0
Emergency Department
Nelson Hospital
Private Bag 18
Nelson 7042
NZ
Country 47078 0
New Zealand
Phone 47078 0
+64 272460187
Fax 47078 0
Email 47078 0
[email protected]
Contact person for public queries
Name 47079 0
Dr Tom Morton
Address 47079 0
Emergency Department
Nelson Hospital
Private Bag 18
Nelson 7042
NZ
Country 47079 0
New Zealand
Phone 47079 0
+643 5461800
Fax 47079 0
Email 47079 0
[email protected]
Contact person for scientific queries
Name 47080 0
Dr Tom Jerram
Address 47080 0
Emergency Department
Nelson Hospital
Private Bag 18
Nelson 7042
NZ
Country 47080 0
New Zealand
Phone 47080 0
+64 3 5461800
Fax 47080 0
Email 47080 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23321Ethical approval   
23322Informed consent form   
23323Statistical analysis plan   
23324Study protocol   

Results publications and other study-related documents

Documents added manually
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4464Study results articleYes NZMJ 30th January 2015, Volume 128 Number 1408 ... [More Details] 366005-(Uploaded-24-07-2019-09-58-20)-Journal results publication.pdf

Documents added automatically
No additional documents have been identified.