Prospective Register on the Etiologies of Cardiogenic Shock and Their Prognosis at One Year. (cardiac shock)

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiogenic Shock

Detailed Description

CC diagnosis remains difficult to carry on admission and is sometimes delayed. Therefore, we would like to compare hemodynamic data from patients with CC status to those admitted for acute heart failure (ICA) to determine if a hemodynamic variable at entry would facilitate the diagnosis of CC.

• Study Type: Observational
• Enrollment (Anticipated): 1650

Contacts and Locations

• Study Contact: Name: bonello laurent; Phone Number: 0491968858; Email: laurent.bonello@ap-hm.fr

Study Locations

• France
  • Paca
    • Marseille, Paca, France, 13354
      • Recruiting
      • Assistance Publique Hopitaux de Marseille
      • Contact: BONELLO LAURENT, PU PH; Phone Number: 0491968858; Email: laurent.bonello@ap-hm.fr

Participation Criteria

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

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

Description

Inclusion Criteria:

• Patients in Cardiac Shock :
• 90 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%.)

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
prevalence of Cardiac Shock	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
mortality	one year
mortality	one month

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2020
• Primary Completion (Anticipated): April 4, 2023
• Study Completion (Anticipated): October 4, 2023

Study Registration Dates

• First Submitted: July 8, 2020
• First Submitted That Met QC Criteria: July 8, 2020
• First Posted (Actual): July 13, 2020

Study Record Updates

• Last Update Posted (Actual): July 13, 2020
• Last Update Submitted That Met QC Criteria: July 8, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Shock; Shock, Cardiogenic
• Other Study ID Numbers: 2019-29; 2019-A01294-53 (Other Identifier: IDRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No