One Year Follow-up After Rescuscited Cardiac Arrest

NCT04796727 | Completed

• 1 other identifier: RECHMPL20_0285
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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 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.

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

Outcome Measures

Primary Outcomes (5)

• 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.

  1 year

• Incidence of patients alive

  Incidence of patients alive Incidence of patients alive without neurological sequelae (CPC 1 or 2)

  3 months

• Incidence of patients alive

  Incidence of patients alive Incidence of patients alive without neurological sequelae (CPC 1 or 2)

  1 year

• Rate of hospitalizations

  Rate of hospitalizations (from cardiovascular cause)

  1 year

• Rate of hospitalizations

  Rate of hospitalizations (from cardiovascular cause)

  3 months

Secondary Outcomes (2)

• Cardiac functional status

  1 year

• Cardiac functional status

  3 months

Study Arms (1)

OHCA

300 OHCA admitted directly to the cathlab and alive at discharge during a 2 years period of enrolement.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients older than 18 who are admitted directly to our cath lab for a cardiopulmonary arrest and alive at discharge.

You may qualify if:

• Older than 18 years old.
• Out of Hospital Cardiac arrest
• Coronary angiography in emergency
• Alive at discharge.

You may not qualify if:

• Absence of return of spontaneous circulation after reanimation.
• Admission in a resuscitation unit before the coronary angiography.
• In-hospital death.

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

Related Publications (2)

• 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.

  PMID: 27627616 RESULT

• von 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.

  PMID: 20210602 RESULT

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Florence Leclercq, PU PH

  University Hospital, Montpellier

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: March 15, 2021
• Study Start: August 1, 2019
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2021
• Last Updated: November 11, 2021

Record last verified: 2021-11

Locations

FR (1)