Cardiac ArrestONYRCANCT04796727
One Year Follow-up After Rescuscited Cardiac Arrest
An observational study of Cardiac Arrest, run by University Hospital, Montpellier at 1 site in France.
Trial summary
While 80 % of all sudden cardiac death (SCD) result from coronary artery disease (CHD) approximatively 2/3 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2019to 1 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients older than 18 who are admitted directly to our cath lab for a cardiopulmonary arrest and alive at discharge.
Who may be able to join
- Older than 18 years old.
- Out of Hospital Cardiac arrest
- Coronary angiography in emergency
- Alive at discharge.
Who cannot join
- Absence of return of spontaneous circulation after reanimation.
- Admission in a resuscitation unit before the coronary angiography.
- In-hospital death.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ONe Year Follow-up in Patients Admitted for Emergency Coronary Angiography After Rescuscited Cardiac Arrest
While 80 % of all sudden cardiac death (SCD) result from coronary artery disease (CHD) approximatively 2/3 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.
Read more
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-up(primary end point). The investigators hypothesize that 10% of patients will discharged alive from hospital with severe neurological sequelae at 1 year.Secondary end point will evaluate cardiac status, quality of life and pronostic factors of adverse outcome.
Read the 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.
- Conditions
- Cardiac Arrest
- Keywords
- neurological state, Cardiological state, Quality of life, Coronary angiography, One year mortality, Cardiac vents, One year quality of life, Neurological events
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| OHCA | 300 OHCA admitted directly to the cathlab and alive at discharge during a 2 years period of enrolement. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of patients alive without neurological sequelae
Incidence of patients alive without neurological sequelae at one year follow up after out of hospital cardiac arrest. Neurological status will be evaluated with the Cerebral Performance Category score. Patients with a score of 1 or 2 will be considered without neurological sequelae. Grade 1 correspond to patients with normal cerebral performance and grade 2 to patients with moderate cerebral disability but don't need any support for daily activities. Grade 3 is for patients with severe disability leading to daily support. Grade 4 is for coma or vegetative state and Grade 5 for brain death.
Measured: 1 year
Incidence of patients alive
Incidence of patients alive Incidence of patients alive without neurological sequelae (CPC 1 or 2)
Measured: 3 months
Incidence of patients alive
Incidence of patients alive Incidence of patients alive without neurological sequelae (CPC 1 or 2)
Measured: 1 year
Rate of hospitalizations
Rate of hospitalizations (from cardiovascular cause)
Measured: 1 year
Rate of hospitalizations
Rate of hospitalizations (from cardiovascular cause)
Measured: 3 months
Secondary outcomes (2)
Cardiac functional status
Cardiac functional status using the NYHA scale (1 or 2 for good functional status)
Measured: 1 year
Cardiac functional status
Cardiac functional status using the NYHA scale (1 or 2 for good functional status)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start1 Aug 2019
- Primary completion1 May 2020
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florence Leclercq, PU PH, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04796727
- Sponsor's protocol ID
- RECHMPL20_0285
- Acronym
- ONYRCA
- Status last verified
- Nov 2021
- First submitted
- 25 Feb 2021
- Last updated
- 11 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Publications
Patel N, Patel NJ, Macon CJ, Thakkar B, Desai M, Rengifo-Moreno P, Alfonso CE, Myerburg RJ, Bhatt DL, Cohen MG. Trends and Outcomes of Coronary Angiography and Percutaneous Coronary Intervention After Out-of-Hospital Cardiac Arrest Associated With Ventricular Fibrillation or Pulseless Ventricular Tachycardia. JAMA Cardiol. 2016 Nov 1;1(8):890-899. doi: 10.1001/jamacardio.2016.2860.
PubMed 27627616von Steinbuchel N, Wilson L, Gibbons H, Hawthorne G, Hofer S, Schmidt S, Bullinger M, Maas A, Neugebauer E, Powell J, von Wild K, Zitnay G, Bakx W, Christensen AL, Koskinen S, Formisano R, Saarajuri J, Sasse N, Truelle JL; QOLIBRI Task Force. Quality of Life after Brain Injury (QOLIBRI): scale validity and correlates of quality of life. J Neurotrauma. 2010 Jul;27(7):1157-65. doi: 10.1089/neu.2009.1077.
PubMed 20210602
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ONe Year Follow-up in Patients Admitted for Emergency Coronary Angiography After Rescuscited Cardiac Arrest
- ClinicalTrials.gov ID
- NCT04796727
- Acronym / sponsor ID
- ONYRCA / RECHMPL20_0285
- Conditions
- Cardiac Arrest
- Keywords
- neurological state, Cardiological state, Quality of life, Coronary angiography, One year mortality, Cardiac vents, One year quality of life, Neurological events
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 15 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
While 80 % of all sudden cardiac death (SCD) result from coronary artery disease (CHD) approximatively 2/3 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-up(primary end point). The investigators hypothesize that 10% of patients will discharged alive from hospital with severe neurological sequelae at 1 year.Secondary 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OHCA | – | –300 OHCA admitted directly to the cathlab and alive at discharge during a 2 years period of enrolement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients older than 18 who are admitted directly to our cath lab for a cardiopulmonary arrest and alive at discharge.
Key inclusion criteria (4 listed)
- Older than 18 years old.
- Out of Hospital Cardiac arrest
- Coronary angiography in emergency
- Alive at discharge.
Key exclusion criteria (3 listed)
- Absence of return of spontaneous circulation after reanimation.
- Admission in a resuscitation unit before the coronary angiography.
- In-hospital death.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of patients alive without neurological sequelae
Time frame: 1 year
Incidence of patients alive without neurological sequelae at one year follow up after out of hospital cardiac arrest. Neurological status will be evaluated with the Cerebral Performance Category score. Patients with a score of 1 or 2 will be considered without neurological sequelae. Grade 1 correspond to patients with normal cerebral performance and grade 2 to patients with moderate cerebral disability but don't need any support for daily activities. Grade 3 is for patients with severe disability leading to daily support. Grade 4 is for coma or vegetative state and Grade 5 for brain death.
Incidence of patients alive
Time frame: 3 months
Incidence of patients alive Incidence of patients alive without neurological sequelae (CPC 1 or 2)
Incidence of patients alive
Time frame: 1 year
Incidence of patients alive Incidence of patients alive without neurological sequelae (CPC 1 or 2)
Rate of hospitalizations
Time frame: 1 year
Rate of hospitalizations (from cardiovascular cause)
Rate of hospitalizations
Time frame: 3 months
Rate of hospitalizations (from cardiovascular cause)
2 secondary outcomes
Cardiac functional status
Time frame: 1 year
Cardiac functional status
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2021.
- Results publication: PubMed 27627616Patel N, Patel NJ, Macon CJ, Thakkar B, Desai M, Rengifo-Moreno P, Alfonso CE, Myerburg RJ, Bhatt DL, Cohen MG. Trends and Outcomes of Coronary Angiography and Percutaneous Coronary Intervention After Out-of-Hospital Cardiac Arrest Associated With Ventricular Fibrillation or Pulseless Ventricular Tachycardia. JAMA Cardiol. 2016 Nov 1;1(8):890-899. doi: 10.1001/jamacardio.2016.2860.
- Results publication: PubMed 20210602von Steinbuchel N, Wilson L, Gibbons H, Hawthorne G, Hofer S, Schmidt S, Bullinger M, Maas A, Neugebauer E, Powell J, von Wild K, Zitnay G, Bakx W, Christensen AL, Koskinen S, Formisano R, Saarajuri J, Sasse N, Truelle JL; QOLIBRI Task Force. Quality of Life after Brain Injury (QOLIBRI): scale validity and correlates of quality of life. J Neurotrauma. 2010 Jul;27(7):1157-65. doi: 10.1089/neu.2009.1077.
- Individual participant dataSharing planned: Undecided. NC
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florence Leclercq, PU PH study director
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrest, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of patients alive without neurological sequelae (time frame: 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04796727, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2021.