Direct or Subacute Coronary Angiography in Out-of-hospital Cardiac Arrest

Out-of-Hospital Cardiac Arrest Clinical Trial

— DISCO  

Official title:

Direct or Subacute Coronary Angiography in Out-of-hospital Cardiac Arrest - a Prospective, Randomized Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02309151
• Other study ID #: DSC001
• Status: Recruiting
• Phase: N/A
• Start date: December 2014
• Est. completion date: December 2024

Study information

• Verified date: June 2024
• Source: Uppsala University
• Contact: Sten Rubertsson Rubertsson, Md,PhD
• Phone: +46708693996
• Email: sten.rubertsson[@]akademiska.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The overall aim of this prospective, randomized study is to investigate whether acute coronary angiography (within 120 minutes) with a predefined strategy for revascularization, will improve 30-day survival in patients with out of hospital cardiac arrest with no signs of ST-elevation on ECG after Restoration of Spontaneous Circulation (ROSC). The patients will be randomized to a strategy of immediate coronary angiography within 120 minutes or to a strategy of delayed angiography that may be performed three days after the cardiac arrest.

Description:

The study is a prospective randomized open label multicenter study with a registry follow up in which patients with out of hospital cardiac arrest without ST-elevation on their first ECG will be randomized to either a strategy of immediate coronary angiography (treatment group) with possible coronary intervention or a strategy of delayed coronary angiography (control group). The study will include in total 1006 patients with Restoration of Spontaneous Circulation (ROSC). Randomization will be done via a web-based module after ECG is taken at the first medical contact but no later than after arrival at the emergency room. Coronary angiography should be performed within 120 minutes from randomization in the immediate angiography group. In the delayed angiography group, angiography with possible coronary intervention will be performed at the discretion of the interventional cardiologist and should preferably not be performed until three days after the cardiac arrest. This strategy is in accordance with standard practice. In case of recurrent chest pain, ST elevation, circulatory instability or cardiogenic shock, cross over to early angiography may occur. The quality of life and health economics will be evaluated at 6 months. The patients will undergo extensive neurocognitive tests and health instruments, these will be analyzed and presented.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1006
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Witnessed out of hospital cardiac arrest

• Restoration of Spontaneous Circulation (ROSC) >20 minutes

• Coronary angiography is expected to be performed within 120 minutes from inclusion and randomization at hospital

Exclusion Criteria:

• Patient age <18 years

• Obvious extracardiac genesis of cardiac arrest such as trauma, hemorrhagic shock, and / or asphyxia (eg drowning, suffocation, hanging, exposure to fire smoke)

• Terminally ill patients with a life expectancy of less than 1 year

• Patients with ST-elevation

• Known pregnancy

• Patient awake GCS >8 (Glasgow Coma Scale)

Related Conditions & MeSH terms

• Heart Arrest
• Out-of-Hospital Cardiac Arrest

Intervention

Procedure:
• Immediate coronary angiography
Immediate coronary angiography for out of hospital cardiac arrest patients with no signs of ST elevation on their first ECG after ROSC

Locations

Country	Name	City	State
Denmark	Aalborg University hospital	Aalborg
Denmark	Aarhus University Hospital	Aarhus
Denmark	Odense University hospital	Odense
Netherlands	Amsterdam UMC	Amsterdam
Netherlands	Albert Schweitzer Hospital	Dordrecht
Netherlands	Catharina Ziekenhuis	Eindhoven
Netherlands	Treant Hospital	Emmen
Netherlands	Zuyderland Hospital	Heerlen
Netherlands	Antonius Hospital	Nieuwegein
Netherlands	Radboud University Medical Center	Nijmegen
Netherlands	Haaglanden Medisch Centrum	The Hague
Sweden	Sahlgrenska Universitetssjukhuset	Göteborg
Sweden	Karolinska Universitetssjukhuset	Huddinge
Sweden	Skånes Universitetssjukhus	Lund
Sweden	Skåne Universitetssjukhus	Malmö
Sweden	Örebro Universitetssjukhus	Örebro
Sweden	Karolinska Universitetssjukhuset	Solna
Sweden	Danderyd Sjukhus	Stockholm
Sweden	Södersjukhuset AB	Stockholm
Sweden	Umeå Universitetssjukhus	Umeå
Sweden	Uppsala University hospital	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University

Countries where clinical trial is conducted

Denmark,  Netherlands,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30 day survival	Follow up will be performed at 30 days, telephone call or visit.	30 days
Secondary	Survival with good neurological function	30-day survival and a follow up of health status, functional outcome associated to cerebral performance and general functional outcome/activities of daily living	30 days
Secondary	Survival at discharge from ICU (individual for each subject) and at 6-months	Recorded in the e-CRF (electronic Case Report Form)	At discharge from ICU, an expected average of 3-30 days and at 6-months
Secondary	Survival with good neurological function at discharge from ICU and 6-months	Survival with good neurological function at discharge and at 6-months. Assessing functional outcome associated to cerebral performance and general functional outcome/activities of daily living and also global functional outcome, independent living and social reintegration at 6-months	At discharge from ICU, an expected average of 3-30 days and at 6-months
Secondary	Cardiac function	Measured with echocardiography	72 hours and at 6 months
Secondary	Follow up of neurological function at 6-months	A 6 month follow up of neurological function will be assessed by validated screening battery in OHCA (Out of Hospital Cardiac Arrest) patients in general functional outcome, activities of daily living, cognitive functioning, attention, anxiety and depression, fatigue, cardiac disease specific health and care giver burden.	Measured at 6 months
Secondary	Hemodynamic parameters (urine output, highest lactate and vasopressor/inotropic support)	Parameters measured daily during ICU care	During ICU care (maximum of 7 days)
Secondary	ECG findings compared to findings at coronary angiography	Primary ECG, performed in the pre-hospital setting or at the emergency department, will be compared with findings at coronary angiography intervention (performed immediately or later during hospital stay depending on randomisation)	During hospital stay up to a maximum of 6-months