Cardiogenic Shock Working Group Registry

NCT04682483 | Recruiting DMC

• 1 other identifier: 12670
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 16

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.

Conditions

Cardiogenic Shock

Keywords

Cardiogenic Shock; mechanical circulatory support; hemodynamics; heart failure; acute myocardial infarction; registry; critical care; clinical outcomes research

Outcome Measures

Primary Outcomes (2)

• Rate of Mortality

  Death in subjects during the time frame.

  30 days after discharge

• Rate of Mortality

  Death in subjects during the time frame.

  1 year after discharge

Secondary Outcomes (4)

• Rate of Re-hospitalization

  30 day after discharge

• Rate of Re-hospitalization

  1 year after discharge

• New York Heart Association (NYHA) Class

  30 day after discharge

• New York Heart Association (NYHA) Class

  1 year after discharge

Study Arms (1)

Cardiogenic Shock Patients

Cardiogenic Shock patients eligible for this study are defined by at least one of the two categories below. 1. Patients have at least 2 of the following concurrently at any point during the index hospitalization: MAP \< 60mmHg or a \>30mmHg drop in MAP from baseline, SBP \< 90mmHg or a \>30mmHg drop in SBP from baseline, Pulse \> 100, Cardiac Index \< 2.2, Cardiac Power Output ≤ 0.6 or PAPI \< 1.0. 2. Patients require the use of at least 1 vasopressor, inotrope or acute mechanical circulatory support device to maintain values above the above targets.

Drug: Vasopressor; Drug: Inotrope; Device: Acute Mechanical Circulatory Support Devices

Interventions

Vasopressor DRUG

The vasopressors include phenylephrine, norepinephrine, epinephrine, dopamine and vasopressin.

Cardiogenic Shock Patients

Inotrope DRUG

Inotropes include dobutamine and milrinone.

Cardiogenic Shock Patients

Acute Mechanical Circulatory Support Devices DEVICE

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.

Cardiogenic Shock Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People who are 18 or older who have an official diagnosis of cardiogenic shock.

You may qualify if:

• 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.

Sponsors & Collaborators

• Tufts Medical Center: lead
• Abbott: collaborator
• Boston Scientific Corporation: collaborator
• Abiomed Inc.: collaborator
• Getinge Group: collaborator

Study Sites (16)

Cleveland Clinic Florida

Weston, Florida, 33331, United States

RECRUITING

Northwestern Medicine

Chicago, Illinois, 60611, United States

RECRUITING

University of Chicago

Chicago, Illinois, 60612, United States

RECRUITING

Maine Medical Center

Portland, Maine, 04102, United States

RECRUITING

Tufts Medical Center

Boston, Massachusetts, 02111, United States

RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

Hackensack Meridian Health

Hackensack, New Jersey, 07601, United States

RECRUITING

Columbia University Irving Medical Center

New York, New York, 10032, United States

RECRUITING

Providence St. Vincent Heart Clinic

Portland, Oregon, 97225, United States

RECRUITING

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

RECRUITING

University Of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15261, United States

RECRUITING

Baylor Scott & White Advanced Heart Failure Clinic

Dallas, Texas, 75201, United States

RECRUITING

University of Texas Medical Branch

Galveston, Texas, 77555, United States

RECRUITING

Houston Methodist Hospital

Houston, Texas, 77030, United States

RECRUITING

Inova Health System

Falls Church, Virginia, 22042, United States

RECRUITING

University of Washington Medical Center

Seattle, Washington, 98195-9472, United States

RECRUITING

Related Publications (10)

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 32900234 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 36342421 DERIVED

• 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.

  PMID: 35835491 DERIVED

MeSH Terms

Conditions

Shock, Cardiogenic; Heart Failure

Interventions

Vasoconstrictor Agents

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Intervention Hierarchy (Ancestors)

Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Reshad Garan, MD

  Beth Israel Deaconess Medical Center

  STUDY DIRECTOR

• Claudius Mahr, DO

  University of Washington

  STUDY DIRECTOR

• Jaime Hernandez-Montfort, MD

  Cleveland Clinic Foundation-Florida

  STUDY DIRECTOR

• Daniel Burkhoff, MD PhD

  CardioVascular Research Foundation

  STUDY DIRECTOR

Central Study Contacts

Navin K Kapur, MD

CONTACT

6176368252; nkapur@tuftsmedicalcenter.org

Study Design

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

Study Record Dates

• First Submitted: December 7, 2020
• First Posted: December 23, 2020
• Study Start: December 4, 2017
• Primary Completion: January 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: June 6, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (16)