To compare major adverse cardiovascular events between non-comatose patients undergoing urgent CAG (within 2 hours after admission) vs. patients who dit not undergo urgent CAG (CAG if indicated after 12-24 hours).
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Major Adverse Cardiovascular Events (MACE): 30-day mortality, cardiogenic
shock, or recurrent cardiac arrest within 30 days from randomization.
Secondary outcome
1. 30-day, 1-year and 5-year mortality.
2. Cardiogenic shock (Lactate>2.5 mmol/l and systolic blood pressure <90 mmHg
or need of inotropic or use of mechanical devices (Impella/VA-ECMO/similar) in
the waiting time for CAG (after randomization) and within 30 days and 1-year
respectively.
3. Recurrent cardiac arrest in the waiting time for CAG (after randomization)
and within 30-day and 5-year, respectively.
4. Shock from ICD I the waiting time for CAG (After randomization), within 30
days and 5-year, respectively.
5. Final cardiac arrest cause: Non-cardiac or cardiac, and for cardiac causes
further subclassification: Acute Myocardial Infarction, Pulmonary Embolism,
Primary Arrhythmia, Aortic Dissection, Other.
6. AMI within 1 year.
7. Readmission with congestive heart failure within 1 year.
8. Proportion revascularized with either PCI or CABG within 30 days and 1 year.
9. Proportion with implantation of ICD within 1 year.
10. Drop in Hgb >=1.86 mmol/l or transfusion of >=2 units of blood within 30 days.
11. Increase in creatinine more than 100% within 30 days.
12. Dialysis within 30 days.
13. Vascular surgery (related to access site) within 30 days.
14. Time from randomization to final diagnosis is established (Evaluated by an
endpoint committee)
15. Hospital length of stay.
16. Proportion with cross-over to acute CAG in cohort B.
17. CPC score and mRS score after 30 day and 6-month.
18. EQ-5D-5L score after 30-day and 6-month.
19. GOSE and MOCA score at 6-month.
Background summary
Out-of-hospital cardiac arrests occur frequently with about 300 cases each week
in the Netherlands. The underlying cause of cardiac arrest often is an acute
myocardial infarction complicated by life threathening cardiac arrhythmias. An
acute myocardial infarction can be recognized by ST segment elevation on the
post-resuscitation ECG. After hospital arrival, these patients undergo urgent
coronary angiography (CAG), with PCI in case a culprit lesion is identified.
Even in the absence of ST segment elevation, we know that coronary artery
disease has often been the cause of cardiac arrest. Therefore, recent (small)
studies have investigated whether urgent CAG results in improved survival in
comatose post-cardiac arrest patients without ST segment when compared to
delayed CAG. This turned out not to be the case; outcomes were not different.
The international randomized DISCO study (Direct or subacute COronary
angiography in out-of-hospital cardiac arrest - DISCO) is still ongoing and is
expected to provide final evidence on this topic. For non-comatose patients,
there is no evidence whatsoever about the diagnostic strategy to be followed.
Therefore, in follow-up of the DISCO study, the randomized DISCO-No-COMA study
compares clinical outcomes (MACE) between non-comatose patients (n=1200)
without ST elevation who underwent urgent CAG vs. those who did not undergo
urgent CAG.
Study objective
To compare major adverse cardiovascular events between non-comatose patients
undergoing urgent CAG (within 2 hours after admission) vs. patients who dit not
undergo urgent CAG (CAG if indicated after 12-24 hours).
Study design
Randomized controlled, international, multicenter trial
Intervention
Acute coronary angiography 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. After one month, a telephone check-up will be performed
and at 6 months an outpatient visit is scheduled including echocardiography.
Palle-Juul Jensens Boulevard 99
Aarhus 8200
DK
Palle-Juul Jensens Boulevard 99
Aarhus 8200
DK
Listed location countries
Age
Inclusion criteria
- Witnessed out-of-hospital cardiac arrest
- Return of spontaneous circulation
- Possible to perform CAG within 120 minutes of randomization
- Glasgow coma scale >8
Exclusion criteria
- Age < 18 years
- Obvious non-cardiac cause for cardiac arrest
- Terminal illness
- ST elevation myocardial infarction
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 | NCT04876222 |
| CCMO | NL81185.091.23 |