In this study we investigate the prehospital use of a Tele-ECG and the CardioDetect. We will use the results to see if help of these diagnostic tools will raise the percentage necessary hospitalisations.We will also investigate the diagnostic…
ID
Source
Brief title
Condition
- Myocardial disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Difference in percentage necessary hospitalisation/ referal to a cardiologist
Secondary outcome
not applicable
Background summary
Most patients who present with myocardial infarction have an atypical
presentation, which makes it for the general practisioner a diagnostical
problem. Several studies have indicated that 20-40% of the events remain
clinically unrecognized. On the other hand, a lot of patients unnecessary will
be refered to a cardiologist. There is a need for new diagnostic tools to
improve the early detection of a myocardial infarction. Telecardiology and the
CardioDetect are reliable and valid tools, with a high diagnostic accuracy for
the early detection of acute myocardial infarction. Prehospital use will raise
necessary hospitalisation and will detect more myocardial infarction.
The diagnostic accuracy of the CardioDetect that we found in our pilotstudy is
not equal to the literature. In this next study it's important to look at the
diagnostic accuracy, the reliability and the validity of this test.
Study objective
In this study we investigate the prehospital use of a Tele-ECG and the
CardioDetect. We will use the results to see if help of these diagnostic tools
will raise the percentage necessary hospitalisations.
We will also investigate the diagnostic accuracy, the reliability and the
validity of the CardioDetect.
Study design
Prospective controlled randomised interventionstudie. Patients that come to the
GP, with atypical complaints will be included. Both the interventiongroup and
controlgroup will be seen by a GP, which will decide his/ her policy by asking
questions and physical examination (care as usual). Patients seen by the GP on
a certain day will form the interventiongroup and get the possibility of a
Tele- ECG and the CardioDetect. The GP also takes blood for early detection of
troponin. Afterwards, the GP can change his/ her policy with help from the
tests and a cardiologist (in case at least one testresult is positive). This
will be noted in the electronic file. Patients seen by the GP on another day
will form the controlegroup, which don't have the possibility of a Tele- ECG
and the CardioDetect. They get care as usual.
Intervention
Diagnostic tools:
-Tele- ECG
-CardioDetect- which will test only h-FABP
Study burden and risks
Almost no burden en risks for the patient. An short interview will normaly be
done and a ECG will take a few minutes. The fingerpunction and the venapunction
give hardly no complications.
Postbus 30001
9700 RB Groningen
Nederland
Postbus 30001
9700 RB Groningen
Nederland
Listed location countries
Age
Inclusion criteria
Atypical complaints:
atypical chest pain, atypical radiation of pain, dyspnea, vertigo, weakness, sweating, vomitting, palor.;De GP has doubts about the diagnoses and doesn't exactly know if there is a cardial cause. There is no suspicion of an acute coronary syndrome and an emergency referal is not needed.
Exclusion criteria
insanity
age < 30 years
recent muscle injury/ recent chest trauma
cardiogenic shock
De GP has a suspicion of an acute coronary syndrome
renal insufficienty
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL21559.099.08 |