CardShock Study and Registry (CardShock)

January 2, 2014 updated by: Veli-Pekka Harjola, Helsinki University Central Hospital

Pathophysiology and Prognostic Factors in Cardiogenic Shock - CardShock Study

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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

220

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland, FI-00029
        • Helsinki UCH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hospitals

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
participants will be followed for 1 year
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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helsinki University Central Hospital

Collaborators

Finnish Foundation for Cardiovascular Research
Aarne Koskelo Foundation

Investigators

  • Principal Investigator: Veli-Pekka Harjola, MD, PhD, Associate professor, Helsinki UCH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

June 9, 2011

First Submitted That Met QC Criteria

June 15, 2011

First Posted (Estimate)

June 16, 2011

Study Record Updates

Last Update Posted (Estimate)

January 3, 2014

Last Update Submitted That Met QC Criteria

January 2, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 117/13/03/01/2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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