Clinical trial NCT04682483: Cardiogenic Shock Working Group Registry
Official title: Cardiogenic Shock Working Group Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiogenic Shock
Keywords: Cardiogenic Shock
mechanical circulatory support
hemodynamics
heart failure
acute myocardial infarction
registry
critical care
clinical outcomes research
Lead sponsor: Tufts Medical Center
Sponsor class: OTHER
Collaborators: name: Abbott
name: Boston Scientific Corporation
name: Abiomed Inc.
name: Getinge Group
First posted: 2020-12-23
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People who are 18 or older who have an official diagnosis of cardiogenic shock.

Brief summary: The Cardiogenic Shock Working Group is a multicenter registry where we collect de-identified clinical variables from the medical records and follow-up phone calls of shock patients from multiple institutions and centralize this data to a single registry for analysis of clinical outcomes.

Detailed description: The Cardiogenic Shock Working Group is an Academic Research Consortium involving multiple medical centers within the United States and includes a multicenter registry for patients with cardiogenic shock. De-identified clinical variables are collected from medical records and follow-up phone calls. There is currently no central database for cardiogenic shock, therefore analysis of cardiogenic shock on a larger scale is limited. A goal of the Cardiogenic Shock Working Group is to create a centralized registry, compiled of data from multiple institutions, to analyze clinical outcomes. The Cardiogenic Shock Working Group Registry will include a retrospective arm, where data is collected during the course of the hospital stay, and a prospective arm, where long-term outcomes will be assessed.

Eligibility criteria: Inclusion Criteria:

* Patients must have cardiogenic shock.

Cardiogenic shock is defined by at least one of the two categories below:

1. At least 2 of the following concurrently at any point during the index hospitalization:

   * Cardiac Index \< 2.2
   * PAPI \< 1.0
   * Cardiac Power Output ≤ 0.6
   * MAP \< 60mmHg or a \>30mmHg drop in MAP from baseline
   * SBP \< 90mmHg or a \>30mmHg drop in SBP from baseline
   * Pulse \> 100
2. Require at least one acute mechanical circulatory support device, vasopressor or inotrope to maintain values above the above target.

Post-cardiotomy patients must meet the inclusion criteria 72 hours after their surgery to be included in this registry.

Primary outcomes:
measure: Rate of Mortality
timeFrame: 30 days after discharge
measure: Rate of Mortality
timeFrame: 1 year after discharge
Secondary outcomes:
measure: Rate of Re-hospitalization
timeFrame: 30 day after discharge
measure: Rate of Re-hospitalization
timeFrame: 1 year after discharge
measure: New York Heart Association (NYHA) Class
timeFrame: 30 day after discharge
measure: New York Heart Association (NYHA) Class
timeFrame: 1 year after discharge
Other outcomes:
Locations:
city: Weston
country: United States
facility: Cleveland Clinic Florida
state: Florida
city: Chicago
country: United States
facility: Northwestern Medicine
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Hackensack
country: United States
facility: Hackensack Meridian Health
state: New Jersey
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
city: Portland
country: United States
facility: Providence St. Vincent Heart Clinic
state: Oregon
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University Of Pittsburgh Medical Center
state: Pennsylvania
city: Dallas
country: United States
facility: Baylor Scott & White Advanced Heart Failure Clinic
state: Texas
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Falls Church
country: United States
facility: Inova Health System
state: Virginia
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Reshad Garan, MD
role: STUDY_DIRECTOR
affiliation: University of Washington
name: Claudius Mahr, DO
role: STUDY_DIRECTOR
affiliation: Cleveland Clinic Foundation-Florida
name: Jaime Hernandez-Montfort, MD
role: STUDY_DIRECTOR
affiliation: CardioVascular Research Foundation
name: Daniel Burkhoff, MD PhD
role: STUDY_DIRECTOR
References:
citation: Kapur NK, Thayer KL, Zweck E. Cardiogenic Shock in the Setting of Acute Myocardial Infarction. Methodist Debakey Cardiovasc J. 2020 Jan-Mar;16(1):16-21. doi: 10.14797/mdcj-16-1-16.
citation: Pahuja M, Chehab O, Ranka S, Mishra T, Ando T, Yassin AS, Thayer KL, Shah P, Kimmelstiel CD, Salehi P, Kapur NK. Incidence and clinical outcomes of stroke in ST-elevation myocardial infarction and cardiogenic shock. Catheter Cardiovasc Interv. 2021 Feb 1;97(2):217-225. doi: 10.1002/ccd.28919. Epub 2020 Apr 30.
citation: Thayer KL, Zweck E, Ayouty M, Garan AR, Hernandez-Montfort J, Mahr C, Morine KJ, Newman S, Jorde L, Haywood JL, Harwani NM, Esposito ML, Davila CD, Wencker D, Sinha SS, Vorovich E, Abraham J, O'Neill W, Udelson J, Burkhoff D, Kapur NK. Invasive Hemodynamic Assessment and Classification of In-Hospital Mortality Risk Among Patients With Cardiogenic Shock. Circ Heart Fail. 2020 Sep;13(9):e007099. doi: 10.1161/CIRCHEARTFAILURE.120.007099. Epub 2020 Sep 9.
citation: Whitehead E, Thayer K, Kapur NK. Clinical trials of acute mechanical circulatory support in cardiogenic shock and high-risk percutaneous coronary intervention. Curr Opin Cardiol. 2020 Jul;35(4):332-340. doi: 10.1097/HCO.0000000000000751.
citation: Kapur NK, Whitehead EH, Thayer KL, Pahuja M. The science of safety: complications associated with the use of mechanical circulatory support in cardiogenic shock and best practices to maximize safety. F1000Res. 2020 Jul 29;9:F1000 Faculty Rev-794. doi: 10.12688/f1000research.25518.1. eCollection 2020.
citation: Garan AR, Kanwar M, Thayer KL, Whitehead E, Zweck E, Hernandez-Montfort J, Mahr C, Haywood JL, Harwani NM, Wencker D, Sinha SS, Vorovich E, Abraham J, O'Neill W, Burkhoff D, Kapur NK. Complete Hemodynamic Profiling With Pulmonary Artery Catheters in Cardiogenic Shock Is Associated With Lower In-Hospital Mortality. JACC Heart Fail. 2020 Nov;8(11):903-913. doi: 10.1016/j.jchf.2020.08.012.
citation: Whitehead EH, Thayer KL, Burkhoff D, Uriel N, Ohman EM, O'Neill W, Kapur NK. Central Venous Pressure and Clinical Outcomes During Left-Sided Mechanical Support for Acute Myocardial Infarction and Cardiogenic Shock. Front Cardiovasc Med. 2020 Aug 28;7:155. doi: 10.3389/fcvm.2020.00155. eCollection 2020.
citation: Pahuja M, Ranka S, Chehab O, Mishra T, Akintoye E, Adegbala O, Yassin AS, Ando T, Thayer KL, Shah P, Kimmelstiel CD, Salehi P, Kapur NK. Incidence and clinical outcomes of bleeding complications and acute limb ischemia in STEMI and cardiogenic shock. Catheter Cardiovasc Interv. 2021 May 1;97(6):1129-1138. doi: 10.1002/ccd.29003. Epub 2020 May 30.
citation: Hernandez-Montfort J, Kanwar M, Sinha SS, Garan AR, Blumer V, Kataria R, Whitehead EH, Yin M, Li B, Zhang Y, Thayer KL, Baca P, Dieng F, Harwani NM, Guglin M, Abraham J, Hickey G, Nathan S, Wencker D, Hall S, Schwartzman A, Khalife W, Li S, Mahr C, Kim J, Vorovich E, Pahuja M, Burkhoff D, Kapur NK. Clinical Presentation and In-Hospital Trajectory of Heart Failure and Cardiogenic Shock. JACC Heart Fail. 2023 Feb;11(2):176-187. doi: 10.1016/j.jchf.2022.10.002. Epub 2022 Oct 31.
citation: Kapur NK, Kanwar M, Sinha SS, Thayer KL, Garan AR, Hernandez-Montfort J, Zhang Y, Li B, Baca P, Dieng F, Harwani NM, Abraham J, Hickey G, Nathan S, Wencker D, Hall S, Schwartzman A, Khalife W, Li S, Mahr C, Kim JH, Vorovich E, Whitehead EH, Blumer V, Burkhoff D. Criteria for Defining Stages of Cardiogenic Shock Severity. J Am Coll Cardiol. 2022 Jul 19;80(3):185-198. doi: 10.1016/j.jacc.2022.04.049.