CardShock Study and Registry

Cardiogenic Shock Clinical Trial

— CardShock  

Official title:

Pathophysiology and Prognostic Factors in Cardiogenic Shock - CardShock Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01374867
• Other study ID #: 117/13/03/01/2010
• Status: Completed
• Phase: N/A
• First received: June 9, 2011
• Last updated: January 2, 2014
• Start date: October 2010
• Est. completion date: December 2013

Study information

• Verified date: January 2014
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Observational

Clinical Trial Summary

The aim of CardShock Study is to recognise significant prognostic factors in order to detect patients with increased mortality risk to which one could possibly direct more intensive treatments.

The study will provide clinical, functional and invasive haemodynamic measures with systematic serial sampling and evaluation. In addition, the knowledge on the pathophysiology of cardiogenic shock is increased.

Description:

Cardiogenic shock (CS) is a life-threatening emergency situation with high hospital mortality up to 50%. Despite of better treatment strategies including early echocardiography, insertion of pulmonary artery catheter to optimize haemodynamic status, early revascularization therapy, and the use of intra-aortic balloon pump, the prognosis has remained poor and only 50% of patients are discharged alive from the hospital. Most commonly CS occurs after a massive ST-elevation myocardial infarction (AMI) - in 8% of AMIs. The importance of early clinical recognition of the developing CS is the crucial since over 2/3 of CS develop only after hospital admission. In addition, about 20% of the cardiogenic shock patients develop systemic inflammatory response syndrome resembling the clinical picture of septic shock. The clinical picture of CS ranges from florid shock to low-output state. The in-hospital length of stay and the costs of care are many times higher than in other shock or AMI patients

Despite the extreme clinical importance of CS, mostly descriptive parameters but not serial evaluation of biomarkers or clinical condition have been analysed. All in all, the scientific data are still very sparse.

Study design

European investigator initiated multicentre study. A minimum of 100 (up to 200) consecutive patients with cardiogenic shock will be recruited in the study. Standardized treatment protocols of the individual participating centres based on international guidelines on heart failure will be applied to every patient in the study. Coronary angiography with percutaneous coronary intervention, vasoactive and inotropic medication, pulmonary artery catheter and intra-aortic balloon pump are utilized when applicable. Echocardiographies and 14-lead ECG will be recorded. Demographic and clinical data as well as serial blood and urine samples (at up to 8 time points during CCU/ICU stay) are collected.

CardShock Registry The patients who are excluded from the study due to time from onset of shock longer than six hours are recorded to Registry (screening failure) log. These patients will form CardShock Registry which includes clinical data (including in-hospital mortality) but not study sampling nor post-discharge follow-up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Cardiogenic shock with hypotension or severe low output syndrome within 6 hours from identification of it Clinical findings of cardiogenic shock: acute heart failure and

• Hypotension (systolic blood pressure under 90mmHg despite adequate fluid challenge) over 30 min time

• OR a need for vasopressor treatment (eg dopamine or norepinephrine) to maintain systolic blood pressure > 90mmHg

• AND signs of hypoperfusion (either altered mental status, cool periphery, oliguria (< 0.5ml/kg/h for last six hours), or blood lactate > 2 mmol/l)

• Age > 18 years

• Written informed consent by patient or a close person or a relative if the patient is unable to give the consent on admission according to local regulations.

Exclusion Criteria:

• Postoperative patients

• Haemodynamically significant ongoing arrhythmia . (However, e.g. patient resuscitated from serious arrhythmia can be included if the arrhythmia is not ongoing at the time of detection of shock)

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiogenic Shock
• Shock, Cardiogenic

Locations

Country	Name	City	State
Finland	Helsinki UCH	Helsinki

Sponsors (3)

Lead Sponsor	Collaborator
Helsinki University Central Hospital	Aarne Koskelo Foundation, Finnish Foundation for Cardiovascular Research

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality	during follow-up additional analyses will be performed after ICU/CCU and total hospital stay,and at 90 and 180 days, In patients with impanted cardioverter defibrillator firing for fatal VTach or VFib is recorded	participants will be followed for 1 year	No
Primary	Major cardiac interventions and implantation of devices	Heart transplant, CABG, valve surgery, PCI etc and implantation of devices LVADs, CRT, ICD etc are recorded during follow-up.	1 year	No
Secondary	Quality of life	The patients will receive EQ5-D questionnaire in their own language and will be asked to fill it at 12 months	1-year	No