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Cardiogenic ShockCSWGNCT04682483

Cardiogenic Shock Working Group Registry

An observational study of Cardiogenic Shock, run by Tufts Medical Center at 16 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cardiogenic Shock
What is being tested?
Vasopressor, Inotrope and Acute Mechanical Circulatory Support Devices
Type of treatment
Medical device
How many people
5,000 participants
Where
16 sitesUnited States
Study dates
4 Dec 2017to 1 Jun 2026
How long will I take part?
1 Year
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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
Show all 11Show fewer
  • 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.

Who cannot join

None listed.

Trial locations and contacts

16 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Navin K Kapur, MD contact

6176368252

nkapur@tuftsmedicalcenter.org

16 sites in 1 country

United States16 sites, 16 recruiting

  • Tufts Medical Center

    Boston, Massachusetts, 02111

    Navin K Kapur, MD, 6176366140, nkapur@tuftsmedicalcenter.org

    Navin Kapur, MD

    Recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

    Arthur R Garan

    Arthur R Garan, MD

    Recruiting

  • Northwestern Medicine

    Chicago, Illinois, 60611

    Esther Vorovich, MD

    Esther Vorovich

    Recruiting

  • University of Chicago

    Chicago, Illinois, 60612

    Sandeep Nathan, MD

    Sandeep Nathan, MD

    Recruiting

  • Baylor Scott & White Advanced Heart Failure Clinic

    Dallas, Texas, 75201

    Detlef Wencker, MD

    Detlef Wencker, MD

    Recruiting

  • Inova Health System

    Falls Church, Virginia, 22042

    Shashank Sinha, MD, MSc

    Shashank Sinha, MD, MSc

    Recruiting

  • University of Texas Medical Branch

    Galveston, Texas, 77555

    Wissam Khalife, MD

    Wissam Khalife

    Recruiting

  • Hackensack Meridian Health

    Hackensack, New Jersey, 07601

    Haroon Faraz, MD

    Haroon Faraz, MD

    Recruiting

  • Houston Methodist Hospital

    Houston, Texas, 77030

    : Ju H Kim, MD

    Ju H Kim, MD

    Recruiting

  • Columbia University Irving Medical Center

    New York, New York, 10032

    Justin Fried, MD

    Justin Fried, MD

    Recruiting

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

    Manreet Kanwar, MD

    Manreet Kanwar, MD

    Recruiting

  • University Of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15261

    Gavin Hickey, MD

    Gavin Hickey, MD

    Recruiting

  • Maine Medical Center

    Portland, Maine, 04102

    Andrew Schwartzman, MD

    Andrew Schwartzman, MD

    Recruiting

  • Providence St. Vincent Heart Clinic

    Portland, Oregon, 97225

    Jacob Abraham, MD

    Jacob Abraham, MD

    Recruiting

  • University of Washington Medical Center

    Seattle, Washington, 98195-9472

    Claudius Mahr, DO

    Claudius Mahr, DO

    Recruiting

  • Cleveland Clinic Florida

    Weston, Florida, 33331

    Jaime Hernandez-Montfort, MD MPH

    Jaime Hernandez-Montfort, MD MPH

    Recruiting

Other trials in United States

About this study

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.

Read the 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.

Being tested
Vasopressor, Inotrope, Acute Mechanical Circulatory Support Devices
Keywords
Cardiogenic Shock, mechanical circulatory support, hemodynamics, heart failure, acute myocardial infarction, registry, critical care, clinical outcomes research
Medical subject headings
Shock, Cardiogenic, Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VasopressorDrug

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

  • InotropeDrug

    Inotropes include dobutamine and milrinone.

  • Acute Mechanical Circulatory Support DevicesDevice

    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.

Study groups in NCT04682483
Study groupRoleWhat they receive
Cardiogenic Shock PatientsCardiogenic 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.
Receives: Drug: Vasopressor; Drug: Inotrope; Device: Acute Mechanical Circulatory Support Devices

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of Mortality

    Death in subjects during the time frame.

    Measured: 30 days after discharge

  2. Rate of Mortality

    Death in subjects during the time frame.

    Measured: 1 year after discharge

Secondary outcomes (4)

  1. 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.

    Measured: 30 day after discharge

  2. 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.

    Measured: 1 year after discharge

  3. 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

    Measured: 30 day after discharge

  4. 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

    Measured: 1 year after discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2020
  2. Study start4 Dec 2017
  3. Primary completion1 Jan 2026 (estimated)
  4. Study completion1 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
5,000 participants (estimated)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT04682483
Sponsor's protocol ID
12670
Acronym
CSWG
Status last verified
Jun 2025
First submitted
7 Dec 2020
Last updated
6 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 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.

    PubMed 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: 10.1161/CIRCHEARTFAILURE.120.007099. Epub 2020 Sep 9.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 32473083

  • 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.

    PubMed 36342421

  • 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.

    PubMed 35835491

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiogenic Shock, run by Tufts Medical Center at 16 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Navin K Kapur, MD (6176368252, nkapur@tuftsmedicalcenter.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Mortality (time frame: 30 days after discharge). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04682483, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2025.

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