To investigate whether a strategy of immediate coronary angiography (within 120 minutes) results in improved 30-day survival of out-of-hospital cardiac arrest patients without ST elevation on the ECG, when compared to no immediate coronary…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
30 day survival
Secondary outcome
- survival with favorable neurologic outcome
- survival to intensive care unit (ICU) discharge, survival to 6 months
- surival with favorable neurologic ouctome at ICU discharge and at 6 months
- cardiac function (ejection fraction) at 72 hours and at 6 months
- neurologic and cognitive dunction, depression, anxiety, quality of life,
fatigue, and relative's situation at 6 months
- hemodynamic parameters during ICU stay
- electrocardiographic findings
Background summary
Cardiac arrest is a leading cause of death in the Western world. Despite
efforts to improve outcome, survival remains poor. In about half of patients,
return of spontaneous circulation is achieved, but only about 23% of patients
survives to discharge. For the subgroup presenting with ventricular
fibrillation as initially observed cardiac rhythm outcome is markedly better,
with about 47% surviving to discharge in the Netherlands. Unfortunately, a
major cause of death in hospital is poor neurologic functioning related to the
period of circulatory arrest.
In a large proportion of patients, the underlying cause of cardiac arrest is an
acute myocardial infarction, resulting from of an occlusion of one of the
coronary vessels. This may lead to life threathening cardiac rhythm disorders
resulting in cardiac arrest. In case of ST elevation of the ECG obtained after
return of spontaneous circulation, we know that the underlying cause of cardiac
arrest was indeed an acute myocardiale infarction, and for this subset of
patients the treatment of choice is immediate coronary angiography with primary
PCI. In contrast, for the subset without ST elevation on the ECG, it is
uncertain whether an immediate coronary anigography is helpful to improve
outcome. Data from observational studies - prone to selection bias - showed
conflicting results. A recently performed, small randomized trial indicated
that a strategy of immedicatie coronary angiography did not improve survival
when compared to a strategy of delayed coronary angiography. This Dutch study
was limited to patients with ventricular fibrillation as initially observed
cardiac rhythm and survival was overall very high, limiting inferences to the
general out-of-hospital cardiac arrest patient. The findings of this study
alone will not result in a class IA recommendation in the guidelines for
cardiopulmonary resuscitation. Moreover, questions regarding the impact on
heart function and neurologic recovery remain. Therefore, additional studies
are eagerly awaited. The DISCO is a large, randomized controlled, European
multicenter study that should improve our understanding of the potential value
of immediate coronary angiography in resuscitated patients without ST
elevation. In the DISCO study, both patients presenting with ventricular
fibrillation as well as with other cardiac rhythms (i.e. asystole, pulseless
electrical activity) will be included. The primary aim is to investigate
whether a strategy of immediate coronary angiography (within 120 minutes)
results in improved 30-day survival of out-of-hospital cardiac arrest patients
without ST elevation on the ECG, when compared to a strategy without immediate
coronary angiography. In the secondary endpoints of the study, specific focus
is put on neurologic functioning during and after hospital discharge.
Study objective
To investigate whether a strategy of immediate coronary angiography (within 120
minutes) results in improved 30-day survival of out-of-hospital cardiac arrest
patients without ST elevation on the ECG, when compared to no immediate
coronary angiography.
Study design
Randomized controlled, international, multicenter trial
Intervention
Acute coronary aniography with - if applicable - coronary revascularization.
Study burden and risks
The risk and burden is related to the coronary angiography. Coronary
angiography is a standard part of the workup of cardiac arrest patients and is
almost always performed. Risks include bleeding at the insertion point and
contrast nephropathy. In the immediate coronary angiography group, patients are
unconscious (shortly after resuscitation) and will not be aware of the
intervention. After one month, a telephone check-up will be performed and at 6
months an outpatient visit is scheduled including echocardiography.
Ing 70 1 tr
Uppsala S-75185
SE
Ing 70 1 tr
Uppsala S-75185
SE
Listed location countries
Age
Inclusion criteria
- Witnessed out-of-hospital cardiac arrest
- Return of spontaneous circulation for more than 20 minutes
- Ability to perform coronary angiography within 120 minutes after
randomization
Exclusion criteria
Age < 18 years
Apparent non-cardiac etiology
ST elevation on the initial ECG
Pregnancy
Conscious patients with a Glasgow Coma Scale >8
Terminally ill patients with an expected survival of less than 1 year
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 |
---|---|
ClinicalTrials.gov | NCT02309151 |
CCMO | NL71318.091.19 |