Ignite Creation Date:
2024-05-06 @ 3:53 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04796727
Status:
COMPLETED
Last Update Posted:
2021-11-11
First Post:
2021-02-25
Brief Title:
One Year Follow-up After Rescuscited Cardiac Arrest
Sponsor:
University Hospital Montpellier
Organization:
University Hospital Montpellier
Study Overview
Official Title:
ONe Year Follow-up in Patients Admitted for Emergency Coronary Angiography After Rescuscited Cardiac Arrest
Status:
COMPLETED
Status Verified Date:
2021-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ONYRCA
Brief Summary:
While 80 of all sudden cardiac death SCD result from coronary artery disease CHD approximatively 23 of SCD occur as a first manifestation of the CHD VF ventricular fibrillation is the main cause of SCD in acute coronary syndrome ACS and the 2017 ESC Guidelines for the management of acute myocardial infarction recommended direct admission to the catheterization laboratory in survivors of out of hospital cardiac arrest OHCA with criteria for STEMI on the post-resuscitation electrocardiogram ECG Class I grade B However During the past few years the number of immediate coronary angiography CA for suspected ACS in patients presenting an OHCA increased with a survival rate at discharge in this subgroup of patients better about 60 to 80 1 However the survival rate remains poor in the global population of OHCA and some survivors patients may have neurological sequelles related to global anoxia consequences or altered quality of life related to cardiac function impairement
While the survival rate at hospital discharge is well known the investigators have few data on long term outcomes particularly regarding cardiac and neurological states
Therefore the main objective of this study is to evaluate prospectively in an observational study the one-year prognosis of patients with rescuscited OHCA in whom a CA for suspected ACS was performed in the university hospital of Montpellier Only patients alive at discharged are considered for the follow-up to eliminate the in-hospital mortality
The investigators aim to assess year neurological status using medical questionnaires at one year follow-upprimary end point The investigators hypothesize that 10 of patients will discharged alive from hospital with severe neurological sequelae at 1 yearSecondary end point will evaluate cardiac status quality of life and pronostic factors of adverse outcome
While the survival rate at hospital discharge is well known the investigators have few data on long term outcomes particularly regarding cardiac and neurological states
Therefore the main objective of this study is to evaluate prospectively in an observational study the one-year prognosis of patients with rescuscited OHCA in whom a CA for suspected ACS was performed in the university hospital of Montpellier Only patients alive at discharged are considered for the follow-up to eliminate the in-hospital mortality
The investigators aim to assess year neurological status using medical questionnaires at one year follow-upprimary end point The investigators hypothesize that 10 of patients will discharged alive from hospital with severe neurological sequelae at 1 yearSecondary end point will evaluate cardiac status quality of life and pronostic factors of adverse outcome
Detailed Description:
Patients older than 18 years old undergoing CA for cardiac arrest discharged alive from hospital will be included from January 1 2018 to May 31 2020
The investigators exclude all the patients who died during the in-hospital stay and patients who had VF immediately rescucitated by electric cardioversion including only unconscious patients at admission in the cath lab Patients were also excluded if they did not receive active in-hospital treatment after cardiac arrest based on either a do-not-attempt-resuscitation order end-stage malignancy preceding the arrest or had minimal chances of meaningful survival defined as not witnessed cardiac arrest with asystole lengthy resuscitation or advanced age
Patient characteristics modalities of cardiac arrest and intra-hospital progress were collected using DxCare software
Cardiac and neurological status will be collected at 1 year follow-up either by using consultation report or by a phone call If available an initial evaluation is done at 3 months
Cerebral Performance Category CPC will be used to assess the neurological functional status Primary end point is the rate of patients with severe neurological sequelae at one year follow-up defined as CPC category 3
Secondary ends points will evaluate the survival rate NYHA functional class rehospitalization and quality of life at 1 year
Quality of life at one year is recorded using the QOLIBRI Quality of Life after Brain Injury which is a novel health-related quality-of-life HRQoL instrument specifically developed for traumatic brain injury TBI 2 It provides a profile of HRQoL in six domains together with an overall score The questionnaire is completed by asking questions by phone to patients available at 1 year follow-up
The inclusion of 96 patients will make possible to highlight a frequency of severe neurological sequelae of 10 percent with a precision of 5 percent width of the confidence interval and considering an alpha risk of 5 percent
Considering that our active patient file include 150 cardiac arrests per year of which 50 are discharged alive per year the inclusion of 96 patients discharged alive from hospital over a 2-year period seems to be realistic
The investigators exclude all the patients who died during the in-hospital stay and patients who had VF immediately rescucitated by electric cardioversion including only unconscious patients at admission in the cath lab Patients were also excluded if they did not receive active in-hospital treatment after cardiac arrest based on either a do-not-attempt-resuscitation order end-stage malignancy preceding the arrest or had minimal chances of meaningful survival defined as not witnessed cardiac arrest with asystole lengthy resuscitation or advanced age
Patient characteristics modalities of cardiac arrest and intra-hospital progress were collected using DxCare software
Cardiac and neurological status will be collected at 1 year follow-up either by using consultation report or by a phone call If available an initial evaluation is done at 3 months
Cerebral Performance Category CPC will be used to assess the neurological functional status Primary end point is the rate of patients with severe neurological sequelae at one year follow-up defined as CPC category 3
Secondary ends points will evaluate the survival rate NYHA functional class rehospitalization and quality of life at 1 year
Quality of life at one year is recorded using the QOLIBRI Quality of Life after Brain Injury which is a novel health-related quality-of-life HRQoL instrument specifically developed for traumatic brain injury TBI 2 It provides a profile of HRQoL in six domains together with an overall score The questionnaire is completed by asking questions by phone to patients available at 1 year follow-up
The inclusion of 96 patients will make possible to highlight a frequency of severe neurological sequelae of 10 percent with a precision of 5 percent width of the confidence interval and considering an alpha risk of 5 percent
Considering that our active patient file include 150 cardiac arrests per year of which 50 are discharged alive per year the inclusion of 96 patients discharged alive from hospital over a 2-year period seems to be realistic
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None