NCT01374867

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 16, 2011

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

January 3, 2014

Status Verified

January 1, 2014

Enrollment Period

3.2 years

First QC Date

June 9, 2011

Last Update Submit

January 2, 2014

Conditions

Cardiogenic Shock

Keywords

Cardiogenic shockMyocardial infarctionLow-output syndromePrognosisBiomarkersPathophysiology

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Secondary Outcomes (1)

  • Quality of life

    1-year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hospitals

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helsinki UCH

Helsinki, FI-00029, Finland

Location

Related Publications (6)

  • Liao Y, Luo D, Zhang X, Liu T, Zhang C. Predictive value of age, estimated glomerular filtration rate and ejection fraction (AGEF) score for all-cause 90-day mortality in patients with cardiogenic shock. J Cardiovasc Med (Hagerstown). 2025 Jun 1;26(6):269-279. doi: 10.2459/JCM.0000000000001729. Epub 2025 May 2.

    PMID: 40472170DERIVED

  • Jantti T, Tarvasmaki T, Harjola VP, Pulkki K, Turkia H, Sabell T, Tolppanen H, Jurkko R, Hongisto M, Kataja A, Sionis A, Silva-Cardoso J, Banaszewski M, DiSomma S, Mebazaa A, Haapio M, Lassus J; CardShock investigators. Predictive value of plasma proenkephalin and neutrophil gelatinase-associated lipocalin in acute kidney injury and mortality in cardiogenic shock. Ann Intensive Care. 2021 Feb 5;11(1):25. doi: 10.1186/s13613-021-00814-8.

    PMID: 33547528DERIVED

  • Jantti T, Tarvasmaki T, Harjola VP, Parissis J, Pulkki K, Javanainen T, Tolppanen H, Jurkko R, Hongisto M, Kataja A, Sionis A, Silva-Cardoso J, Banaszewski M, Spinar J, Mebazaa A, Lassus J; CardShock investigators. Hypoalbuminemia is a frequent marker of increased mortality in cardiogenic shock. PLoS One. 2019 May 16;14(5):e0217006. doi: 10.1371/journal.pone.0217006. eCollection 2019.

    PMID: 31095609DERIVED

  • Tolppanen H, Rivas-Lasarte M, Lassus J, Sadoune M, Gayat E, Pulkki K, Arrigo M, Krastinova E, Sionis A, Parissis J, Spinar J, Januzzi J, Harjola VP, Mebazaa A; CardShock Investigators. Combined Measurement of Soluble ST2 and Amino-Terminal Pro-B-Type Natriuretic Peptide Provides Early Assessment of Severity in Cardiogenic Shock Complicating Acute Coronary Syndrome. Crit Care Med. 2017 Jul;45(7):e666-e673. doi: 10.1097/CCM.0000000000002336.

    PMID: 28403119DERIVED

  • Tolppanen H, Rivas-Lasarte M, Lassus J, Sans-Rosello J, Hartmann O, Lindholm M, Arrigo M, Tarvasmaki T, Kober L, Thiele H, Pulkki K, Spinar J, Parissis J, Banaszewski M, Silva-Cardoso J, Carubelli V, Sionis A, Harjola VP, Mebazaa A. Adrenomedullin: a marker of impaired hemodynamics, organ dysfunction, and poor prognosis in cardiogenic shock. Ann Intensive Care. 2017 Dec;7(1):6. doi: 10.1186/s13613-016-0229-2. Epub 2017 Jan 4.

    PMID: 28050899DERIVED

  • Harjola VP, Lassus J, Sionis A, Kober L, Tarvasmaki T, Spinar J, Parissis J, Banaszewski M, Silva-Cardoso J, Carubelli V, Di Somma S, Tolppanen H, Zeymer U, Thiele H, Nieminen MS, Mebazaa A; CardShock Study Investigators; GREAT network. Clinical picture and risk prediction of short-term mortality in cardiogenic shock. Eur J Heart Fail. 2015 May;17(5):501-9. doi: 10.1002/ejhf.260. Epub 2015 Mar 28.

    PMID: 25820680DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma, urine

MeSH Terms

Conditions

Shock, CardiogenicMyocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisShock

Study Officials

  • Veli-Pekka Harjola, MD, PhD, Associate professor

    Helsinki UCH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician

Study Record Dates

First Submitted

June 9, 2011

First Posted

June 16, 2011

Study Start

October 1, 2010

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

January 3, 2014

Record last verified: 2014-01

Locations

FI(1)