Cardiogenic Shock Working Group Registry

Cardiogenic Shock Clinical Trial

— CSWG  

Official title:

Cardiogenic Shock Working Group Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04682483
• Other study ID #: 12670
• Status: Recruiting
• Start date: December 4, 2017
• Est. completion date: June 1, 2025

Study information

• Verified date: February 2024
• Source: Tufts Medical Center
• Contact: Navin K Kapur, MD
• Phone: 6176368252
• Email: nkapur[@]tuftsmedicalcenter.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: June 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiogenic Shock
• Shock
• Shock, Cardiogenic

Intervention

Drug:
• Vasopressor
The vasopressors include phenylephrine, norepinephrine, epinephrine, dopamine and vasopressin.
• 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.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Tufts Medical Center	Boston	Massachusetts
United States	Northwestern Medicine	Chicago	Illinois
United States	University of Chicago	Chicago	Illinois
United States	Baylor Scott & White Advanced Heart Failure Clinic	Dallas	Texas
United States	Inova Health System	Falls Church	Virginia
United States	University of Texas Medical Branch	Galveston	Texas
United States	Hackensack Meridian Health	Hackensack	New Jersey
United States	Houston Methodist Hospital	Houston	Texas
United States	Columbia University Irving Medical Center	New York	New York
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	University Of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Maine Medical Center	Portland	Maine
United States	Providence St. Vincent Heart Clinic	Portland	Oregon
United States	University of Washington Medical Center	Seattle	Washington
United States	Cleveland Clinic Florida	Weston	Florida

Sponsors (5)

Lead Sponsor	Collaborator
Tufts Medical Center	Abbott, Abiomed Inc., Boston Scientific Corporation, Getinge Group

Country where clinical trial is conducted

United States, 

References & Publications (8)

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 Cardi — View 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. — View 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. — View 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; — View 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. Cath — View 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 Hemodynami — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Mortality	Death in subjects during the time frame.	30 days after discharge
Primary	Rate of Mortality	Death in subjects during the time frame.	1 year after discharge
Secondary	Rate of Re-hospitalization	We will be observing if patient was hospitalized again during the 1 year-time frame. We will collect information on surgeries and interventions during the course of rehospitalization.	30 day after discharge
Secondary	Rate of Re-hospitalization	We will be observing if patient was hospitalized again during the 1 year-time frame. We will collect information on surgeries and interventions during the course of rehospitalization.	1 year after discharge
Secondary	New York Heart Association (NYHA) Class	NYHA Classification provides a way to classify the stages of heart failure. Class I- No symptoms and no limitation in ordinary physical activity Class II- Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity Class IV - Severe limitations	30 day after discharge
Secondary	New York Heart Association (NYHA) Class	NYHA Classification provides a way to classify the stages of heart failure. Class I- No symptoms and no limitation in ordinary physical activity Class II- Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity Class IV - Severe limitations	1 year after discharge