Investigating immediate versus delayed coronary angiography for cardiac arrest patients
Direct or Subacute Coronary Angiography in Out-of-hospital Cardiac Arrest - a Prospective, Randomized Study
NA · Uppsala University · NCT02309151
This study is testing if doing heart imaging right after a cardiac arrest can help people survive longer compared to waiting a few days to do the imaging.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 1006 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Uppsala University (other) |
| Locations | 21 sites (Aalborg and 20 other locations) |
| Trial ID | NCT02309151 on ClinicalTrials.gov |
What this trial studies
This prospective, randomized study aims to determine if performing acute coronary angiography within 120 minutes improves 30-day survival rates in patients who experience out-of-hospital cardiac arrest without ST-elevation on their ECG after restoration of spontaneous circulation. Participants will be randomly assigned to receive either immediate coronary angiography or delayed angiography, which may occur three days post-arrest. The study will include 1006 patients and will assess quality of life and health economics at six months, alongside extensive neurocognitive testing.
Who should consider this trial
Good fit: Ideal candidates are adults who have experienced a witnessed out-of-hospital cardiac arrest with restoration of spontaneous circulation lasting more than 20 minutes and no ST-elevation on their ECG.
Not a fit: Patients under 18 years old, those with ST-elevation on ECG, or those with obvious extracardiac causes of cardiac arrest will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve survival rates for patients experiencing out-of-hospital cardiac arrest.
How similar studies have performed: Previous studies have explored similar approaches, but this specific strategy of immediate versus delayed angiography in this patient population is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Aalborg and 20 other locations
- Aalborg University hospital — Aalborg, Denmark (TERMINATED)
- Aarhus University Hospital — Aarhus, Denmark (RECRUITING)
- Odense University hospital — Odense, Denmark (RECRUITING)
- Amsterdam UMC — Amsterdam, Netherlands (RECRUITING)
- Albert Schweitzer Hospital — Dordrecht, Netherlands (RECRUITING)
- Catharina Ziekenhuis — Eindhoven, Netherlands (RECRUITING)
- Treant Hospital — Emmen, Netherlands (RECRUITING)
- Zuyderland Hospital — Heerlen, Netherlands (RECRUITING)
- Antonius Hospital — Nieuwegein, Netherlands (RECRUITING)
- Radboud University Medical Center — Nijmegen, Netherlands (RECRUITING)
- Haaglanden Medisch Centrum — The Hague, Netherlands (RECRUITING)
- Sahlgrenska Universitetssjukhuset — Göteborg, Sweden (RECRUITING)
- Karolinska Universitetssjukhuset — Huddinge, Sweden (TERMINATED)
- Skånes Universitetssjukhus — Lund, Sweden (TERMINATED)
- Skåne Universitetssjukhus — Malmö, Sweden (TERMINATED)
- Karolinska Universitetssjukhuset — Solna, Sweden (RECRUITING)
- Danderyd Sjukhus — Stockholm, Sweden (TERMINATED)
- Södersjukhuset AB — Stockholm, Sweden (RECRUITING)
- Umeå Universitetssjukhus — Umeå, Sweden (RECRUITING)
- Uppsala University hospital — Uppsala, Sweden (RECRUITING)
- Örebro Universitetssjukhus — Örebro, Sweden (TERMINATED)
Study contacts
- Principal investigator: Sten Rubertsson, Md,PhD — Uppsala Universtiy hospital
- Study coordinator: Sten Rubertsson Rubertsson, Md,PhD
- Email: sten.rubertsson@akademiska.se
- Phone: +46708693996
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Out-of-Hospital Cardiac Arrest