Coronariography in OUt of hosPital Cardiac arrEst

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2021-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Prospective, multicenter, randomized clinical trial. Survivors from an out-of-hospital cardiac arrest (OHCA) without ST segment elevation in their EKG will be recruited. Potentially non-cardiac etiology of the cardiac arrest will be ruled out prior to randomization. Primary goal (treatment): to evaluate the efficacy of urgent vs deferred coronary angiography in survivors from OHCA without ST-segment elevation in the EKG.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

EMERGEncy Versus Delayed Coronary Angiogram in Survivors of Out-of-hospital Cardiac Arrest

NCT02876458

Out-of-Hospital Cardiac Arrest

COMPLETED NA

Coronary Angiography in Critically Ill Patients With Type II Myocardial Infarction

NCT04043091

Type 2 Myocardial Infarction Coronary Artery Disease Percutaneous Coronary Intervention +1 more

WITHDRAWN NA

Impact of Ischemic Post-conditioning

NCT04068116

ST Elevation Myocardial Infarction Ventricular Remodeling Ventricular Dysfunction +1 more

UNKNOWN NA

Direct or Subacute Coronary Angiography in Out-of-hospital Cardiac Arrest

NCT02309151

Out-of-Hospital Cardiac Arrest

RECRUITING NA

Cangrelor in Patients With Acute Myocardial Infarction Undergoing PCI After CPR, Ventilated or Cardiogenic Shock

NCT04611607

Acute Myocardial Infarction

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Prospective, multicenter and randomized clinical trial. Survivors from Out-of-Hospital Cardiac Arrest (OHCA) who do not show ST elevation in their EKG will be recruited in the present study. Potentially non-cardiac ethiology of the cardiac arrest will be ruled out prior to randomization. Afterwards, patients will be randomized to emergent or deferred (performed before discharge) coronary angiography. Both groups will receive routine care in the Acute Cardiac Care Unit, including therapeutic hypothermia.

The randomization will be in a 1:1 ratio to urgent or deferred coronary angiography.

The main objective of the study is to compare the effectiveness of an urgent coronary angiography and angioplasty if necessary versus a deferred coronary angiography in survivors from OHCA who after recovery of spontaneous circulation do not fulfill criteria for ST-elevation myocardial infarction.

The primary efficacy endpoint is a composite of in-hospital survival and six-month survival free of severe dependence, which will be evaluated by using the Cerebral Performance Category (CPC) Scale, being good prognosis represented by the categories 1 and 2.The safety endpoint will be a composite of MACE (Major Adverse Cardiac Events) including: death, reinfarction, bleeding or ventricular arrhythmias.

A total of 166 patients will be included. The estimated duration will be 42 months, with a target follow-up of 6 months. Periods will be divided as follows:

* Inclusion Period (selection of the population and data collection): 36 months.
* Monitoring, data analysis, statistical and clinical report: 6 months.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiac Arrest

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Urgent Coronary Angiography

Urgent Coronary Angiography: as soon as possible, when the patient is randomized.

Group Type EXPERIMENTAL

Urgent Coronary Angiography

Intervention Type PROCEDURE

Diagnostic test for the evaluation of the coronary vasculature.

Deferred coronariography

Deferred coronary angiography: after extubation if the patient has a good neurologic prognosis.

Group Type ACTIVE_COMPARATOR

Deferred Coronary Angiography

Intervention Type PROCEDURE

Diagnostic test for the evaluation of the coronary vasculature.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Urgent Coronary Angiography

Diagnostic test for the evaluation of the coronary vasculature.

Intervention Type PROCEDURE

Deferred Coronary Angiography

Diagnostic test for the evaluation of the coronary vasculature.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Remain comatose after recovery of spontaneous circulation (ROSC) (Glasgow Coma Scale score equal or less than 8).
* Show a non-diagnostic electrocardiogram after ROSC (neither ST segment elevation nor left bundle branch block).
* Prior rule out of an obvious non-cardiac cause of the cardiac arrest (head CT scan and transthoracic echocardiogram).

Exclusion Criteria

* Age \<18 years.
* Pregnant women or women of childbearing age unless they have a negative pregnancy test.
* Time to return of spontaneous circulation longer than 60 minutes.
* Non-cardiac etiology of the comatose state: drug overdose, head injury or stroke.
* Acute myocardial infarction with ST segment elevation or left bundle branch block, because in those patients emergent angiography is mandatory.
* Hemodynamic instability (refractory cardiogenic shock despite vasoactive drugs or refractory arrhythmias), because in those patients an emergent angiography is mandatory.
* Known coagulopathy or bleeding.
* Refusal to participate in the study by the next of kin.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No