Clincosm LogoSign in Get a demo

Cardiac Catheterization in Cardiac Arrest

Sponsor
Lawson Health Research Institute (Other)
Overall Status
Unknown status
CT.gov ID
NCT02587494
Collaborator
(none)
75
Enrollment
1
Location
2
Arms
12
Anticipated Duration (Months)
6.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a pilot study that will lead to a large randomized control trial (RCT), to assess whether early versus late or no cardiac catheterization is associated with improved outcomes in out-of-hospital cardiac arrest (OHCA) patients.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Cardiac catheterization
 N/A

Detailed Description

A pilot multicenter RCT.

The objectives of the study are:

To assess whether early (within 12 hours) cardiac catheterization is associated with improved survival, neurologic and cardiovascular outcomes in OHCA patients.

Patients will be randomized 1:1 to early cardiac catheterization, performed as early as possible, within 12h post return of spontaneous circulation (ROSC) following OHCA, or to standard practice, which may include medical management without cardiac catheterization or late cardiac catheterization after completion of therapeutic hypothermia. Percutaneous coronary intervention (PCI) is recommended for culprit lesions found on diagnostic angiography. All patients will undergo therapeutic hypothermia started as soon as possible with target temperature below 36°C according to local practice. Other medical management will be according to standard of care

Study Design

Study Type:
Interventional
Anticipated Enrollment :
75 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Role of Early Cardiac Catheterization in Cardiac Arrest
Anticipated Study Start Date :
Dec 1, 2017
Anticipated Primary Completion Date :
Dec 1, 2018
Anticipated Study Completion Date :
Dec 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Early cardiac catheterization

Cardiac catheterization performed as early as possible, within 12h post ROSC following OHCA, with possible PCI during mild therapeutic hypothermia or apyrexia

Procedure: Cardiac catheterization
Cardiac catheterization / coronary angiography is a diagnostic procedure used to define the coronary anatomy and presence of obstructive coronary lesions or culprit lesions. According to the findings, it may lead to percutaneous coronary intervention (PCI) using stents
Other Names:
  • Coronary angiography

    		•
    No Intervention: Medical arm

    Initial therapy does not include cardiac catheterization. Cardiac catheterization with possible PCI is allowed after completion of mild therapeutic hypothermia or apyrexia for >24h post ROSC.

    Outcome Measures

    Primary Outcome Measures

    1. Composite of death and poor neurologic outcomes ( Cerebral Performance Category [CPC] score 3-5). [30 days]

    Secondary Outcome Measures

    1. Death [30 day]

    2. CPC score [up to 30 days]

    3. Acute kidney injury- creatinine levels [48 hours]

      Number of participants with increase in serum creatinine of ≥44.2 μmol/L, or a 25% relative rise in creatinine, within 48 h after contrast exposure42

    4. Myocardial infarction - according to cardiac troponin levels [30 days]

      Number of participants with myocardial infarction post percutaneous coronary interventions, in accordance with the universal definition of myocardial infarction.

    5. Stent thrombosis by pathology or angiography [30 days]

      Number of participants with definite stent thrombosis confirmed by angiography or pathology according to the Academic research consortium criteria

    6. Bleeding - according to Hb levels [30 days]

      Number of participant with overt bleeding according to Academic Research Consortium criteria

    7. Composite of death and poor neurologic outcome [1 year]

    8. Stroke - imaging or pathology [30 days]

      New stroke following hypothermia confirmed by imaging (computer tomography or magnetic resonance imaging)

    9. Heart failure (NYHA 3-4) [30 days]

    10. Estimated cost per patient according to length of stay and procedures performed [30 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Glasgow Coma Scale score <8 on hospital admission following OHCA of presumed cardiac cause.

    • Initial rhythm ventricular tachycardia (VT) / ventricular fibrillation (VF), who achieved ROSC sustained for >20 consecutive minutes

    Exclusion Criteria:

    • ST-elevation on any of the ECGs post resuscitation

    • Hypothermia <30°C

    • Interval from ROSC to screening of >12h

    • Suspected or known acute intracranial hemorrhage or stroke

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 London Health Sciences Centre London Ontario Canada N6A5A5

    Sponsors and Collaborators

    • Lawson Health Research Institute

    Investigators

    • Principal Investigator: Shahar Lavi, MD, London Health Sciences Centre

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shahar Lavi, Principal Investigator, Lawson Health Research Institute
    ClinicalTrials.gov Identifier:
    NCT02587494
    Other Study ID Numbers:
    • 106834
    First Posted:
    Oct 27, 2015
    Last Update Posted:
    Aug 23, 2017
    Last Verified:
    Aug 1, 2017
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Heart Arrest
    Out-of-Hospital Cardiac Arrest

    Study Results

    No Results Posted as of Aug 23, 2017