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CardShock Study and Registry (CardShock)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01374867
Recruitment Status : Completed
First Posted : June 16, 2011
Last Update Posted : January 3, 2014
Aarne Koskelo Foundation
Finnish Foundation for Cardiovascular Research
Information provided by (Responsible Party):
Veli-Pekka Harjola, Helsinki University Central Hospital

Tracking Information
First Submitted Date June 9, 2011
First Posted Date June 16, 2011
Last Update Posted Date January 3, 2014
Study Start Date October 2010
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 15, 2011)
  • All-cause mortality [ Time Frame: participants will be followed for 1 year ]
    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
  • Major cardiac interventions and implantation of devices [ Time Frame: 1 year ]
    Heart transplant, CABG, valve surgery, PCI etc and implantation of devices LVADs, CRT, ICD etc are recorded during follow-up.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 15, 2011)
Quality of life [ Time Frame: 1-year ]
The patients will receive EQ5-D questionnaire in their own language and will be asked to fill it at 12 months
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title CardShock Study and Registry
Official Title Pathophysiology and Prognostic Factors in Cardiogenic Shock - CardShock Study
Brief 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.

Detailed 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.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
plasma, urine
Sampling Method Non-Probability Sample
Study Population Hospitals
Condition Cardiogenic Shock
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 2, 2014)
Original Estimated Enrollment
 (submitted: June 15, 2011)
Actual Study Completion Date December 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

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)
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Finland
Removed Location Countries  
Administrative Information
NCT Number NCT01374867
Other Study ID Numbers 117/13/03/01/2010
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Veli-Pekka Harjola, Helsinki University Central Hospital
Study Sponsor Helsinki University Central Hospital
  • Aarne Koskelo Foundation
  • Finnish Foundation for Cardiovascular Research
Principal Investigator: Veli-Pekka Harjola, MD, PhD, Associate professor Helsinki UCH
PRS Account Helsinki University Central Hospital
Verification Date January 2014