Cardiogenic Shock in the Setting of Acute Myocardial Infarction.
Navin K Kapur, Katherine L Thayer, Elric Zweck
https://pubmed.ncbi.nlm.nih.gov/32280413Actively Recruiting
Age: 18Years +
All Genders
ID04682483
Cardiogenic Shock Working Group Registry
Led by Tufts Medical Center · Updated on 2025-06-06
5000
Participants Needed
16
Research Sites
21 weeks
Total Duration
On this page
Sponsors
T
Tufts Medical Center
Lead Sponsor
A
Abbott
Collaborating Sponsor
AI-Summary
What this Trial Is About
The Cardiogenic Shock Working Group Registry is a multicenter effort to collect and centralize de-identified clinical data from patients experiencing cardiogenic shock. This registry includes data from multiple institutions across the United States and aims to analyze clinical outcomes in this patient group. Because there is no existing central database for cardiogenic shock, this registry seeks to fill that gap by compiling comprehensive information for better understanding of the condition. The registry has two main parts: a retrospective arm that collects data from hospital stays and a prospective arm that follows patients over time to assess long-term outcomes. The study includes patients who meet specific clinical criteria for cardiogenic shock, such as low blood pressure readings, abnormal heart function measures, or the need for vasopressors, inotropes, or mechanical circulatory support devices. Data collected includes use of medications like vasopressors and inotropes and devices such as ECMO and Impella. Participants' medical records and follow-up phone calls are used to gather information without identifying personal details. Researchers will track outcomes like mortality rates at 30 days and one year after discharge, rates of rehospitalization, and heart function class at these time points. This observational registry does not involve experimental treatments; instead, it collects existing clinical data to improve knowledge about cardiogenic shock and its outcomes.
CONDITIONS
Brief Title
Cardiogenic Shock Working Group Registry
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients must have cardiogenic shock.
- Cardiogenic shock is defined by either at least 2 of the following concurrently during hospitalization: Cardiac Index below 2.2, PAPI below 1.0, Cardiac Power Output less than or equal to 0.6, MAP below 60mmHg or a 30mmHg drop from baseline, SBP below 90mmHg or a 30mmHg drop from baseline, Pulse over 100.
- Patients requiring at least one acute mechanical circulatory support device, vasopressor, or inotrope to maintain these targets.
- Post-cardiotomy patients must meet these criteria at least 72 hours after surgery to be included.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or via medical record review)
Monitoring
Duration - During the index hospitalization
Participants who undergo routine care for cardiogenic shock are observed through collection of de-identified clinical data during their hospital stay.
Data collected from medical records during hospitalization
Long-term Monitoring
Duration - Up to 1 year after discharge
Participants are followed up with phone calls to assess long-term clinical outcomes after discharge.
Follow-up phone calls at 30 days and 1 year after discharge
Trial Site Locations
Total: 16 locations
1
Cleveland Clinic Florida
Weston, Florida, United States, 33331
Actively Recruiting
2
Northwestern Medicine
Chicago, Illinois, United States, 60611
Actively Recruiting
3
University of Chicago
Chicago, Illinois, United States, 60612
Actively Recruiting
4
Maine Medical Center
Portland, Maine, United States, 04102
Actively Recruiting
5
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Actively Recruiting
6
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
7
Hackensack Meridian Health
Hackensack, New Jersey, United States, 07601
Actively Recruiting
8
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
9
Providence St. Vincent Heart Clinic
Portland, Oregon, United States, 97225
Actively Recruiting
10
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
Actively Recruiting
11
University Of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15261
Actively Recruiting
12
Baylor Scott & White Advanced Heart Failure Clinic
Dallas, Texas, United States, 75201
Actively Recruiting
13
University of Texas Medical Branch
Galveston, Texas, United States, 77555
Actively Recruiting
14
Houston Methodist Hospital
Houston, Texas, United States, 77030
Actively Recruiting
15
Inova Health System
Falls Church, Virginia, United States, 22042
Actively Recruiting
16
University of Washington Medical Center
Seattle, Washington, United States, 98195-9472
Actively Recruiting
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Research Team
N
Navin K Kapur, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
Incidence and clinical outcomes of stroke in ST-elevation myocardial infarction and cardiogenic shock.
Mohit Pahuja, Omar Chehab, Sagar Ranka...
https://pubmed.ncbi.nlm.nih.gov/32352638Invasive Hemodynamic Assessment and Classification of In-Hospital Mortality Risk Among Patients With Cardiogenic Shock.
Katherine L Thayer, Elric Zweck, Mohyee Ayouty...
https://pubmed.ncbi.nlm.nih.gov/32900234Clinical trials of acute mechanical circulatory support in cardiogenic shock and high-risk percutaneous coronary intervention.
Evan Whitehead, Katherine Thayer, Navin K Kapur
https://pubmed.ncbi.nlm.nih.gov/32487943The science of safety: complications associated with the use of mechanical circulatory support in cardiogenic shock and best practices to maximize safety.
Navin K Kapur, Evan H Whitehead, Katherine L Thayer...
https://pubmed.ncbi.nlm.nih.gov/32765837Complete Hemodynamic Profiling With Pulmonary Artery Catheters in Cardiogenic Shock Is Associated With Lower In-Hospital Mortality.
A Reshad Garan, Manreet Kanwar, Katherine L Thayer...
https://pubmed.ncbi.nlm.nih.gov/33121702Central Venous Pressure and Clinical Outcomes During Left-Sided Mechanical Support for Acute Myocardial Infarction and Cardiogenic Shock.
Evan H Whitehead, Katherine L Thayer, Daniel Burkhoff...
https://pubmed.ncbi.nlm.nih.gov/33005634Incidence and clinical outcomes of bleeding complications and acute limb ischemia in STEMI and cardiogenic shock.
Mohit Pahuja, Sagar Ranka, Omar Chehab...
https://pubmed.ncbi.nlm.nih.gov/32473083Clinical Presentation and In-Hospital Trajectory of Heart Failure and Cardiogenic Shock.
Jaime Hernandez-Montfort, Manreet Kanwar, Shashank S Sinha...
https://pubmed.ncbi.nlm.nih.gov/36342421Criteria for Defining Stages of Cardiogenic Shock Severity.
Navin K Kapur, Manreet Kanwar, Shashank S Sinha...
https://pubmed.ncbi.nlm.nih.gov/35835491