Cardiac Catheterization in Cardiac Arrest

NCT02587494 | Unknown

• 1 other identifier: 106834
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Out of Hospital Cardiac Arrest

Outcome Measures

Primary Outcomes (1)

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

  30 days

Secondary Outcomes (10)

• Death

  30 day

• CPC score

  up to 30 days

• Acute kidney injury- creatinine levels

  48 hours

• Myocardial infarction - according to cardiac troponin levels

  30 days

• Stent thrombosis by pathology or angiography

  30 days

Study Arms (2)

Early cardiac catheterization

ACTIVE COMPARATOR

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

Medical arm

NO INTERVENTION

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.

Interventions

Cardiac catheterization PROCEDURE

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

Also known as: Coronary angiography

Early cardiac catheterization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A5A5, Canada

Location

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest

Interventions

Cardiac Catheterization

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Catheterization; Therapeutics; Investigative Techniques

Study Officials

• Shahar Lavi, MD

  London Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shahar Lavi, MD

CONTACT

519-6633611; shahar.lavi@lhsc.on.ca

Mistre Alemayehu

CONTACT

519-6633611; mistre.alemayehu@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 27, 2015
• First Posted: October 27, 2015
• Study Start: December 1, 2017
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: August 23, 2017

Record last verified: 2017-08

Locations

CA (1)