Aim of the COACT trial is to compare a strategy of immediate coronary angiography followed by percutaneous coronary intervention (PCI) if indicated with delayed coronary angiography in patients presenting at the emergency department after out of…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary end point of the study is 90-days survival
Secondary outcome
Secondary endpoints are 90-days survival with good, minor or moderate
disability, myocardial injury measured by troponine and CK MB as area under the
curve, occurrence off acute kidney injury, need for renal replacement therapy,
time to target hypothermia, neurological status at ICU discharge and duration
of inotropic support, left ventricular function on cardiac ultrasound or MRI
(if available), functional performance measured with the RAND 36 questionnaire
at 1 year and MACE and survival at 1 and 5 years.
Background summary
Cardiac arrest is one of the leading causes of death in the western world.
Patients after a succesfull resuscitation are frequently presented to the ER.
Although the resuscitation was succesfull and circulation was restored, most
patients are unconscious and mechanically ventilated. The prognoses of these
patients remains poor due to damage to brain and heart. If the EKG shows signs
of a lage myocardial infarction (STEMI), there is a indication for acute
coronary angiography and primairy PCI. This is based on several randomised
trials in patients with STEMI (although patients after cardiac arrest were
often not included in these trials). In resuscitated patients without signs of
STEMI the quistion also rises wether an acute coronary angiography will benefit
the patient before being admitted to the ICU. This is based on several
observational studies who have shown a survival benefit in patients after acute
coronary angiography. These studies are however not radomised and subject to
selection bias. Futhermore several radomised trials showed an acute coronary
angiography not to be superior to delayed coronary angiography in patients with
non ST segment elevation myocardial infarction (NSTEMI) who were not
resuscitated. To answer this important clinical question a randomised trial is
necessary.
Study objective
Aim of the COACT trial is to compare a strategy of immediate coronary
angiography followed by percutaneous coronary intervention (PCI) if indicated
with delayed coronary angiography in patients presenting at the emergency
department after out of hospital cardiac arrest without signs of a ST segment
elevation myocardial infarction (STEMI) and no obvious non-cardiac aetiology.
This will be the first randomised trial adressing this subject and will have
the potential to influence international guidelines.
Study design
study is a prospective, randomized controlled, multi-centre study
Intervention
The patients will be randomized to either the immediate or delayed coronary
angiography and subsequent revascularisation group
Study burden and risks
The risk and burden consists of early or late CAG. If PCI is indicated, early
CAG will turn into a benefit by preventing further myocardial ischemia. If no
indication for PCI is found, the CAG will be futile. This may be the case in
both groups . During early CAG, the patient is under anaesthesia and will not
be aware of the intervention. Potential medical risks of futile CAG include
access site bleeding and contrast induced nephropathy One of the treatment
groups may have better outcome.
Boelelaan 1117
Amsterdam 1081 HV
NL
Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
Age > 18
Comatose patients (Glasgow coma score < 8) with ROSC after OHCA
Ventricular tachycardia or ventricular fibrillation as initial arrest rhythm
Without signs of STEMI.
Exclusion criteria
Signs of STEMI on the ECG at the emergency department (including new LBTB or
isolated ST depression in V1-V3 due to an true posterior infarct).
Hemodynamic instability unresponsive to medical therapy (defined as a systolic
blood pressure < 90 mm Hg).
An obvious or suspected non cardiac aetiology of the cardiac arrest.
A known severe renal dysfunction. (GRF< 30 ml/min)
Obvious or suspected pregnancy
Suspected or confirmed acute intracranial bleeding
Suspected or confirmed acute stroke
Known limitations in therapy or DO Not Resuscitate-order.
Known pre-arrest Cerebral Performance Category 3 or 4
>4 hours (240 min from ROSC to screening
Known inability to complete 90 day follow up
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 |
|---|---|
| CCMO | NL49015.029.14 |
| OMON | NL-OMON23168 |