Evaluation of eCPR Survivors

Study Overview
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Brief Summary
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A cardiac arrest event has severe impact on the patient´s health-related quality of life. Survival of cardiac arrest does not innately translate to favorable quality of life. In particular, highly invasive resuscitation strategies, including extracorporeal cardio-pulmonary resuscitation (ECPR) due to therapy-refractory cardiac arrest, may have impact on long-term outcomes. Therefore, apart from acute medical treatment and physical rehabilitation, long-term effects on cardio-pulmonary, physical and neuro-psychiatric functions after cardiac arrest survival have to be evaluated and optimized. We plan to investigate a bundle of cardio-pulmonary, physical and neuro-psychiatric functions in patients who survived a therapy-refratory cardiac arrest with ECPR.

Official Title
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Evaluation of Cardio-pulmonary, Physcial and Neuro-psychiatric Function in Patients Who Survived a Therapy-refractory Cardiac Arrest With Extracorporeal Cardiopulmonary Resuscitation.

Conditions
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Cardiac Arrest, Cardiopulmonary Resuscitation, Extracorporeal Membrane Oxygenation Complication, Myocardial Infarction, Cardiogenic Shock

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients Survival of cardiac arrest Use of extracorporeal cardiopulmonary resuscitation (ECPR) with veno-arterial extracorporeal membrane oxygenation (VA-ECMO) or ECMELLA (VA-ECMO and left-ventricular Impella micro-axial pump) Exclusion Criteria: Non-adult patients No cardiac arrest No use of ECPR Inability to comply with follow-up

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ECPR survivor<br>Adult patient who survived therapy-refractory cardiac arrest with extracorporeal cardiopulmonary resuscitation (ECPR). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular ejection fraction (LVEF) | LVEF measured with transthoracic echocardiography. | LVEF witihin one year after index cardiac arrest event. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive function | Cognitive function measured with a standardized questionnaire and following established scores: Mini-mental-status-test [0-30 points; higher score means better outcome], Cerebral Performance Categories Scale [1-5; lower score means better outcome]. | Cognitive function witihin one year after index cardiac arrest event. | 
| Sign and symptoms of heart failure | Sign and symptoms of heart failure measured with a standardized questionnaire and following established score: European Quality of Life 5 Dimensions 3 Level Version [0-100 points; higher score means better outcome]. | Sign and symptoms of heart failure witihin one year after index cardiac arrest event. | 
| Activity of daily living (ADL) | ADL measured with a standardized questionnaire and following estbalished score: Barthel index [0-100 points; higher score means better outcome]. | ADL witihin one year after index cardiac arrest event. | 
| Comorbidity level | Comorbidity level measured with following established score: Charlson comorbidity index [0-24 points; lower score means better outcome]. | Comorbidity level witihin one year after index cardiac arrest event. | 
| Number of cardiovascular medications | Number of cardiovascular medications documented with a standardized questionnaire. | Number of cardiovascular medication witihin one year after index cardiac arrest event. | 
| Cardiac stress test: Ergometry | Quantitative test to evaluate cardiopulmonary exercise tolerance and physical capacity by using a bicycle. | Physical function witihin one year after index cardiac arrest event. | 
| Cardiac stress test: Walking distance | Quantitative test to evaluate endurance and aerobic capacity by walking for six minutes (six minute walk test). | Physical function witihin one year after index cardiac arrest event. | 
| Vital function: Blood pressure | Non-invasive blood pressure measurement at rest (unit: mmHg). | Blood pressure witihin one year after index cardiac arrest event. | 
| Vital function: Electrocardiogram (ECG) | 12-lead ECG measurement at rest. | ECG activity witihin one year after index cardiac arrest event. | 
| Vital function: Peripheral oxygen saturation | Peripheral oxygen saturation measurement at rest by using pulsoximetry (unit: percent). | Peripheral oxygen saturation witihin one year after index cardiac arrest event. |