Cardiac Catheterization in Cardiac Arrest

Out of Hospital Cardiac Arrest Clinical Trial

Official title:

Role of Early Cardiac Catheterization in Cardiac Arrest

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02587494
• Other study ID #: 106834
• Status: Not yet recruiting
• Phase: N/A
• First received: August 27, 2015
• Last updated: August 22, 2017
• Start date: December 2017
• Est. completion date: December 2018

Study information

• Verified date: August 2017
• Source: Lawson Health Research Institute
• Contact: Shahar Lavi, MD
• Phone: 519-6633611
• Email: shahar.lavi[@]lhsc.on.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 75
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Arrest
• Out of Hospital Cardiac Arrest
• Out-of-Hospital Cardiac Arrest

Intervention

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

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of death and poor neurologic outcomes ( Cerebral Performance Category [CPC] score 3-5).		30 days
Secondary	Death		30 day
Secondary	CPC score		up to 30 days
Secondary	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
Secondary	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
Secondary	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
Secondary	Bleeding - according to Hb levels	Number of participant with overt bleeding according to Academic Research Consortium criteria	30 days
Secondary	Composite of death and poor neurologic outcome		1 year
Secondary	Stroke - imaging or pathology	New stroke following hypothermia confirmed by imaging (computer tomography or magnetic resonance imaging)	30 days
Secondary	Heart failure (NYHA 3-4)		30 days
Secondary	Estimated cost per patient according to length of stay and procedures performed		30 days