To compare the diagnostic value of CTA versus the standard work-up in terms of identifying patients with severe coronary artery disease (requiring revascularization), as well as the ability to safely discharge patients without coronary artery…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1) The proportion of patients discharged from the ED without adverse events in
the following 30 days. Adverse events are defined as death, non-fatal
myocardial infarction or coronary revascularisation.
2) The diagnostic yield is defined as the number of patients with severe
coronary artery disease (by invasive angiography). Severe coronary artery
disease is defined as a flow limiting or highly vulnerable plaque in one or
more vessels, requiring revascularization according to established guidelines.
Secondary outcome
a) Successful discharge rate for all adverse events (at 30 days): death,
non-fatal MI, unstable angina, coronary revascularization, and repeat hospital
visits for chest pain.
b) Composite endpoint of major adverse cardiac events at 6 months: cardiac
death, non-fatal myocardial infarction, unstable angina and repeats hospital
visits for chest pain.
c) Diagnosis of acute coronary syndrome (cardiovascular death, myocardial
infarction, instable angina according to the European guidelines of
cardiology16) at time of discharge.
d) Late myocardial ischemia (at 2-day follow-up).
e) Duration of hospital stay.
f) Direct medical costs until 30th day after ED visit.
g) Radiation exposure
Background summary
The current work up of suspected acute coronary syndrome, based on
presentation, symptoms, ECG and biomarkers, is not efficient and results in
unnecessary diagnostics and hospital admissions, as well as errors or delayed
diagnoses, in a substantial number of patients. Computed tomography angiography
(CTA) images atherosclerosis, coronary obstruction as well as myocardial
hypoperfusion. We hypothesize that early use of CTA is of incremental value and
allows for accurate and immediate triage of patients with acute chest pain.
Study objective
To compare the diagnostic value of CTA versus the standard work-up in terms of
identifying patients with severe coronary artery disease (requiring
revascularization), as well as the ability to safely discharge patients without
coronary artery disease or other potentially life-threatening conditions.
Study design
This study is designed as a single as well as a multicenter randomized
controlled trial with distinctive study endpoints. In the single center
(Erasmus MC) part we will assess whether CTA will allow safe ED discharged
without any major cardiac adverse events in the next 30 days.
In collaboration with other hospitals we will be able to recruit a sufficient
number of patients to assess whether the CT approach will identify more
patients with severe coronary artery disease (by invasive angiography,
requiring revascularization).
Participating patients presenting with acute chest pain, suspected of having an
ACS, are randomly allocated to either the control group with the standard
work-up, based on European guidelines or to the intervention group with
diagnostic workup with CTA.
The diagnostic accuracy and efficiency of coronary CTA on patient management
will be evaluated. Patients will be recruited from the emergency ward over a
period of approximately 18 months. Blood analysis and ECG will be repeated two
days after visiting the ER in patients who were immediately discharged without
observation. Further follow-up will take place after 30 days (out patient
clinic) and 6 months (telephone interview, or mailed questionnaire), mortality
records and hospital records.
Intervention
Diagnostic intervention with replacement of the standard optimal care (based
upon serial blood testing and stresst testing) by a strategy based upon cardiac
CT-scan.
Study burden and risks
1) Patients will receive iodine contrast medium. Known allergies or kidney
dysfunction are contraindications to iodine contrast. The risk of kidney
dysfunction is small in patients with a normal kidney function (which will be
checked). Allergic reactions are rare. Medication and personnel is available to
deal with unexpected reactions. Patients with minimal or uncertain reactions in
the past will be pre-medicated with H2-antagonists and corticosteroids.
Contrast extravasation can cause skin damage but it is rare and can be limited
by special extravasation detectors.
2) The total radiation dose is <5 mSv for CT angiography, which is more than
the annual background exposure, but less than catheter angiography or nuclear
imaging. The associated risks are considered to be very small.
The CT examination is generally well tolerated, probably better than the
cardiac catheterization or hospital admission which will be more frequent in
the standard care group.
Time burden:
There are no significant physical burdens. In terms of time, participation will
take a few hours over 6 months, consisting of two hospital visits and one
questionnaire.
Benefits & group relatedness:
If the hypothesis is correct, then patients that underwent CT will benefit. In
general, participation to the study benefits similar patients in the future.
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
Acute chest pain or equivalent possibly caused by coronary artery disease. Age >30 years, ability and willingness to provide informed consent.
Exclusion criteria
History of significant CAD, defined as prior myocardial infarction, percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) surgery.
Very low likelihood of an ACS, based on demographics, risk factors and
presentation (normal ECG and initial markers), without clinical requirement for observation or further investigation.
Very high-risk ACS with need for immediate coronary angiography (<90 minutes), according to clinical guidelines.
Troponins > 0.1, high risk patients who will require early invasive angiography (<48 hrs).
Clinical instability: clinical heart failure and hemodynamic instability
Contra-indications to CT: kidney failure, allergic reactions to contrast media, pregnancy
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 | NL35422.078.11 |