Cardiogenic Shock Working Group Registry

Overview

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.

Interventions

• Drug Vasopressor
  The vasopressors include phenylephrine, norepinephrine, epinephrine, dopamine and vasopressin.
• Drug Inotrope
  Inotropes include dobutamine and milrinone.
• Device Acute Mechanical Circulatory Support Devices
  Acute Mechanical Circulatory Support devices include ECMO (VV), ECMO (VA), Impella CP, Impella 2.5, Impella 5.0, Impella 5.5, Impella RP, IABP, Centrimag, Tandem Heart and ProTek Duo.

Primary outcome measures

• Rate of Mortality [Time frame: 30 days after discharge]
• Rate of Mortality [Time frame: 1 year after discharge]

Secondary outcome measures (4)

• Rate of Re-hospitalization [Time frame: 30 day after discharge]
• Rate of Re-hospitalization [Time frame: 1 year after discharge]
• New York Heart Association (NYHA) Class [Time frame: 30 day after discharge]
• New York Heart Association (NYHA) Class [Time frame: 1 year after discharge]

Eligibility criteria

Inclusion criteria

• Patients must have cardiogenic shock.

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

• 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
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

United States · 16 centers

• Cleveland Clinic Florida — Weston
• Northwestern Medicine — Chicago
• University of Chicago — Chicago
• Maine Medical Center — Portland
• Tufts Medical Center — Boston
• Beth Israel Deaconess Medical Center — Boston
• Hackensack Meridian Health — Hackensack
• Columbia University Irving Medical Center — New York
• … and 8 more centers

Publications

• 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. PMID 32280413
• 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. PMID 32352638
• 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 PMID 32900234
• 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. PMID 32487943
• 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. PMID 32765837
• 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. PMID 33121702
• 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. PMID 33005634
• 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. PMID 32473083

Identifiers

NCT: NCT04682483 · 12670

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗