Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
5000 participants
OBSERVATIONAL
2017-12-04
2026-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Study Groups
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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.
Vasopressor
The vasopressors include phenylephrine, norepinephrine, epinephrine, dopamine and vasopressin.
Inotrope
Inotropes include dobutamine and milrinone.
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.
Interventions
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Vasopressor
The vasopressors include phenylephrine, norepinephrine, epinephrine, dopamine and vasopressin.
Inotrope
Inotropes include dobutamine and milrinone.
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.
Eligibility Criteria
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Inclusion Criteria
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.
18 Years
ALL
No
Sponsors
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Abbott
INDUSTRY
Boston Scientific Corporation
INDUSTRY
Abiomed Inc.
INDUSTRY
Getinge Group
OTHER
Tufts Medical Center
OTHER
Responsible Party
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Principal Investigators
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Reshad Garan, MD
Role: STUDY_DIRECTOR
Beth Israel Deaconess Medical Center
Claudius Mahr, DO
Role: STUDY_DIRECTOR
University of Washington
Jaime Hernandez-Montfort, MD
Role: STUDY_DIRECTOR
Cleveland Clinic Foundation-Florida
Daniel Burkhoff, MD PhD
Role: STUDY_DIRECTOR
CardioVascular Research Foundation
Locations
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Cleveland Clinic Florida
Weston, Florida, United States
Northwestern Medicine
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Maine Medical Center
Portland, Maine, United States
Tufts Medical Center
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Hackensack Meridian Health
Hackensack, New Jersey, United States
Columbia University Irving Medical Center
New York, New York, United States
Providence St. Vincent Heart Clinic
Portland, Oregon, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
University Of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Baylor Scott & White Advanced Heart Failure Clinic
Dallas, Texas, United States
University of Texas Medical Branch
Galveston, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
Inova Health System
Falls Church, Virginia, United States
University of Washington Medical Center
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Jaime Hernandez-Montfort, MD MPH
Role: primary
Esther Vorovich, MD
Role: primary
Sandeep Nathan, MD
Role: primary
Andrew Schwartzman, MD
Role: primary
Arthur R Garan
Role: primary
Haroon Faraz, MD
Role: primary
Justin Fried, MD
Role: primary
Jacob Abraham, MD
Role: primary
Manreet Kanwar, MD
Role: primary
Gavin Hickey, MD
Role: primary
Detlef Wencker, MD
Role: primary
Wissam Khalife, MD
Role: primary
Wissam Khalife
Role: backup
: Ju H Kim, MD
Role: primary
Shashank Sinha, MD, MSc
Role: primary
Claudius Mahr, DO
Role: primary
References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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12670
Identifier Type: -
Identifier Source: org_study_id
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