Evaluation of eCPR Survivors

Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05339854
• Other study ID #: ECPR Outpatient Clinic
• Status: Not yet recruiting
• Start date: June 1, 2023
• Est. completion date: March 30, 2024

Study information

• Verified date: May 2023
• Source: Charite University, Berlin, Germany
• Contact: Tharusan Thevathasan, MD
• Phone: +49 30 450 613 687
• Email: tharusan.thevathasan[@]charite.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: March 30, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Germany	Charité - Universitätsmedizin Berlin	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Universitätsklinikum Düsseldorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left ventricular ejection fraction (LVEF)	LVEF measured with transthoracic echocardiography.	LVEF witihin one year after index cardiac arrest event.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Vital function: Blood pressure	Non-invasive blood pressure measurement at rest (unit: mmHg).	Blood pressure witihin one year after index cardiac arrest event.
Secondary	Vital function: Electrocardiogram (ECG)	12-lead ECG measurement at rest.	ECG activity witihin one year after index cardiac arrest event.
Secondary	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.