Early Coronary Angiography Versus Delayed Coronary Angiography

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 16-001541
    NCT ID: NCT02387398
    Sponsor Protocol Number: 16-001541

About this study

This study is a pilot, multi-centered, randomized, clinical trial to evaluate the safety and efficacy of performing early Coronary Angiography (CAG) versus no early CAG in post-cardiac arrest patients without ST segment elevation. Safety will be assessed by evaluating the association of major adverse events (re-arrest, bleeding, pulmonary edema, hypotension, acute renal insufficiency, and pneumonia) with early coronary angiogram. Efficacy will be assessed by a composite endpoint of improved left ventricular regional and global function (both regional wall motion analysis and left ventricular ejection fraction) as measured by echocardiography prior to hospital discharge and favourable neurological function (Cerebral Performance Categories 1 or 2) at discharge.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  1. All successfully resuscitated out-of-hospital cardiac arrest patients with a suspected cardiac etiology for their non-traumatic arrest
  2. Age greater than 18 years
  3. The post resuscitation ECG shows no evidence of ST segment elevation

Exclusion Criteria:

  1. Non-resuscitated (no sustained pulse and BP)
  2. Presence ST segment elevation or new left bundle branch block present on the post-resuscitation ECG
  3. Suspected non-cardiac etiology for their arrest such as respiratory failure, asphyxia, pulmonary embolus, shock, trauma, drug overdose, or CNS bleed as likely cause of the cardiac arrest
  4. Known "Do Not Resuscitate" status
  5. Minors (<18 years old)
  6. Prisoners
  7. Significant bleeding or blunt trauma
  8. Known or confirmed pregnancy test by urinalysis
  9. Patients who are known to have received any other investigational therapies within the 30 days prior to enrollment or during study duration will be excluded unless these studies have been reviewed and approved by the Study Steering Committee.
  10. Known "opt out" choice; wearing Opt-out band for any EFIC approved study or on an "Opt-out" list

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Jacob Jentzer, M.D.

Open for enrollment

Contact information:

Jacob Jentzer M.D.

(507)255-2398

pearlstudy@mayo.edu

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CLS-20258279

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