NCT04467294

Brief Summary

Cardiogenic shock (CC) is one of the major challenges of current cardiology. Despite the difficulty of establishing a strict and consensual definition, it is accepted that the CC clinically corresponds to persistent hypotension (systolic blood pressure 90 mmHg for at least 30 minutes or need for vasopressor support) associated with signs of visceral hypoperfusion (confusion, mottling, oliguria, hyperlactatemia), and hemodynamic with a lowered heart index ( 1.8 L/min/m2) despite appropriate or high filling pressures. This definition of the European Society of Cardiology (ESC) masks however the great variability of hemodynamic tables grouped under the term of CC and severity levels, also variable.However, it was suggested that the etiology of CC influenced both its hemodynamic profile and therefore its therapeutic management but also its prognosis in the medium and long term.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,650

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

April 4, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 13, 2020

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 4, 2023

Completed
Last Updated

July 13, 2020

Status Verified

July 1, 2020

Enrollment Period

3 years

First QC Date

July 8, 2020

Last Update Submit

July 8, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • prevalence of Cardiac Shock

    12 months

Secondary Outcomes (2)

  • mortality

    one month

  • mortality

    one year

Eligibility Criteria

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

Patients in Cardiac Shock and patients admitted for acute heart failure (ICA)

You may qualify if:

  • Patients in Cardiac Shock :
  • mmHg hypotension or requiring inotropic or vasopressor support,
  • owered cardiac output ( 1.8 L/min/m2) to trans-thoracic cardiac ultrasound with high or normal filling pressures
  • peripheral hypoperfusion. patients admitted for acute heart failure (ICA) (Acute pulmonary edema chart or left congestive heart failure without CC sign and with ultrasound FEVG at entry 40%.)

You may not qualify if:

  • Pregnant or nursing women
  • Age 18 years
  • Person of full age under guardianship
  • Staying in a health or social facility
  • Person not covered by a social security scheme
  • Person deprived of liberty
  • Shocks from other etiologies
  • Patient with initial cardiac arrest
  • Patient with cardiogenic shock due to right ventricular dysfunction
  • Patient with pulmonary embolism
  • Patient with tamponade
  • Refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, PACA, 13354, France

RECRUITING

MeSH Terms

Conditions

Shock, Cardiogenic

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisShock

Study Officials

  • Garrido-pradalie Emilie

    ASSISTANCE PUBLIQUE HÔPITAUX DE MARSEILLE

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2020

First Posted

July 13, 2020

Study Start

April 4, 2020

Primary Completion

April 4, 2023

Study Completion

October 4, 2023

Last Updated

July 13, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations