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Cardiac Catheterization in Cardiac Arrest

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ClinicalTrials.gov Identifier: NCT02587494
Recruitment Status : Not yet recruiting
First Posted : October 27, 2015
Last Update Posted : August 23, 2017
Sponsor:
Information provided by (Responsible Party):
Shahar Lavi, Lawson Health Research Institute

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
Out of Hospital Cardiac Arrest Procedure: Cardiac catheterization Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : December 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


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 Name: 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.



Primary Outcome Measures :
  1. Composite of death and poor neurologic outcomes ( Cerebral Performance Category [CPC] score 3-5). [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Death [ Time Frame: 30 day ]
  2. CPC score [ Time Frame: up to 30 days ]
  3. Acute kidney injury- creatinine levels [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 30 days ]
    Number of participant with overt bleeding according to Academic Research Consortium criteria

  7. Composite of death and poor neurologic outcome [ Time Frame: 1 year ]
  8. Stroke - imaging or pathology [ Time Frame: 30 days ]
    New stroke following hypothermia confirmed by imaging (computer tomography or magnetic resonance imaging)

  9. Heart failure (NYHA 3-4) [ Time Frame: 30 days ]
  10. Estimated cost per patient according to length of stay and procedures performed [ Time Frame: 30 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02587494


Contacts
Contact: Shahar Lavi, MD 519-6633611 shahar.lavi@lhsc.on.ca
Contact: Mistre Alemayehu 519-6633611 mistre.alemayehu@lhsc.on.ca

Locations
Canada, Ontario
London Health Sciences Centre Not yet recruiting
London, Ontario, Canada, N6A5A5
Contact: Shahar Lavi, MD    519-663-3611    shahar.lavi@lhsc.on.ca   
Contact: Mistre Alemayehu, MSc    519-685-8500 ext 35625    mistre.alemayehu@lhsc.on.ca   
Principal Investigator: Shahar Lavi, MD         
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Shahar Lavi, MD London Health Sciences Centre

Responsible Party: Shahar Lavi, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT02587494     History of Changes
Other Study ID Numbers: 106834
First Posted: October 27, 2015    Key Record Dates
Last Update Posted: August 23, 2017
Last Verified: August 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
Heart Diseases
Cardiovascular Diseases