Cardiac Catheterization in Cardiac Arrest

Role of Early Cardiac Catheterization in Cardiac Arrest

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.

Study Overview

• Status: Unknown
• Conditions: Out of Hospital Cardiac Arrest
• Intervention / Treatment: Procedure: Cardiac catheterization

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
• Enrollment (Anticipated): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A5A5
      • London Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death		30 day
CPC score		up to 30 days
Acute kidney injury- creatinine levels	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	48 hours
Myocardial infarction - according to cardiac troponin levels	Number of participants with myocardial infarction post percutaneous coronary interventions, in accordance with the universal definition of myocardial infarction.	30 days
Stent thrombosis by pathology or angiography	Number of participants with definite stent thrombosis confirmed by angiography or pathology according to the Academic research consortium criteria	30 days
Bleeding - according to Hb levels	Number of participant with overt bleeding according to Academic Research Consortium criteria	30 days
Composite of death and poor neurologic outcome		1 year
Stroke - imaging or pathology	New stroke following hypothermia confirmed by imaging (computer tomography or magnetic resonance imaging)	30 days
Heart failure (NYHA 3-4)		30 days
Estimated cost per patient according to length of stay and procedures performed		30 days

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Investigators: Principal Investigator: Shahar Lavi, MD, London Health Sciences Centre

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2017
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: August 27, 2015
• First Submitted That Met QC Criteria: October 26, 2015
• First Posted (Estimate): October 27, 2015

Study Record Updates

• Last Update Posted (Actual): August 23, 2017
• Last Update Submitted That Met QC Criteria: August 22, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest; Out-of-Hospital Cardiac Arrest
• Other Study ID Numbers: 106834

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No