To determine if the ESC ACS guidelines (the currently used 0h/3h rapid rule out protocol, as well as the future 0h/1h rapid rule out protocol) can be applied for ruling out ACS on the ED/CCU for patients with cocaine associated chest pain.
ID
Source
Brief title
Condition
- Cardiac disorders, signs and symptoms NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary parameter is the development of ACS. The end point is >4 weeks after
presentation.
Secondary outcome
Secondary endpoints are: observation time on the department; re-admittance to
hospital after discharge; recurrent chest pain with presentation to medical
specialist; recurrent chest pain without presentation to medical specialist; no
recurrent chest pain symptoms, discontinuation or continued cocaine abuse.
Background summary
No protocol for the treatment of cocaine associated chest pain (CACP) is
subscribed by the Dutch Cardiology association or the Dutch association for
Emergency Medicine. The American Heart Association refers to a review article
in their advice for a twelve hour observation period in patients with CACP to
exclude the development of an AMI. This advice is based on limited and outdated
literature, without the use of modern high sensitive troponins. A questionnaire
amongst Dutch emergency physicians and cardiologist reveals that there is a
variety in treatment and observation times for CACP patients, but the majority
treats ands observes patients according to the ESC ACS guidelines. Therefor we
can speak of this guideline as the standard of care for treatment of CACP, in
contrary to the 12 hour observation period as advices in the outdated protocol
of the AHA. This conclusion provided the hypothesis for this study: the ESC ACS
guideline is valid for exclusion of ACS in patients with CACP.
This guideline advises discharge of CACP patients with a low- to intermediate
cardiac risk profile if there are no abnormalities on the EKG suspect for
STelevated myocardial infarct (STEMI) and if there is no relevant rise in
cardiac enzymes. According to the ESC ACS guidline there are 2 algorithms to
decide relevant rise in troponins: 1) an algorithm in which a relevant rise can
be detected after 3 hours with use of high sensitivity troponins (0h/3h rapid
rule out protocol); 2) ) an algorithm in which a relevant rise can be detected
after 1 hours with use of high sensitivity troponins (0h/1h rapid rule out
protocol). Both algorithms are valid. The first algorithm is the general
standard of care, the second algorithm is new, and therefor not widely
implemented yet. This implementation is expected to be very soon though,
depending on financial agreements with health care insurances.
Study objective
To determine if the ESC ACS guidelines (the currently used 0h/3h rapid rule
out protocol, as well as the future 0h/1h rapid rule out protocol) can be
applied for ruling out ACS on the ED/CCU for patients with cocaine associated
chest pain.
Study design
The study design will be a multi center, prospective, observational cohort
study.
Study burden and risks
Subjects will be asked for their participation and will have to sign an
informed consent form. The subjects will be treated according to the current
standard of care with addition of the soon to be applied new standard of care
(the currently used 0h/3h rapid rule out protocol, as well as the future 0h/1h
rapid rule out protocol). This includes blood sample collection according to
both protocols, ECG administration, full medical history and history of
symptoms with analysis of cardiac risk factors and associated drug of abuse.
Urine will be collected for drug analysis. This is all according to current
standard practice, except for one extra blood sample to validate the future
standard of care.
After discharge subjects will be contacted once by telephone or by email for
follow up. If the subject can not be contacted and informed consent for
contacting the GP has been given, the GP will be contacted once for follow up.
Questions will be asked according to the primary and secundary study parameters
(re-admittance to hospital after discharge; recurrent chest pain with
presentation to medical specialist; recurrent chest pain without presentation
to medical specialist; no recurrent chest pain symptoms, discontinuation or
continued cocaine abuse). No information other than standard information after
visiting the hospital will be sent to the GP.
Oosterpark 9
Amsterdam 1091 AC
NL
Oosterpark 9
Amsterdam 1091 AC
NL
Listed location countries
Age
Inclusion criteria
-Acute chest pain symtoms
-low- to intermediate cardiac risk profile
-anamnestically positive for cocaine use past 4 days
-age > 18 years - < 46 years and toxicology screening positive for cocaine
Exclusion criteria
-high cardiac risk profile
-non english speaking
-other clearly diagnosed non cardiac causes of chest pain.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
Other | NTR5500 |
CCMO | NL57552.100.16 |
OMON | NL-OMON22767 |