National Cardiogenic Shock Initiative (NCSI)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03677180|
Recruitment Status : Recruiting
First Posted : September 19, 2018
Last Update Posted : August 7, 2019
|Condition or disease|
|Cardiogenic Shock Acute Myocardial Infarction STEMI - ST Elevation Myocardial Infarction NSTEMI - Non-ST Segment Elevation MI Heart Attack|
Acute myocardial infarction complicated by cardiogenic shock (AMICS) is a deadly condition with a historical in-hospital survival of only 50%. To date, the only therapy proven to benefit patients in AMICS using data from randomized control trials has been early mechanical reperfusion. Accordingly, current American and European guidelines confer a class IB indication for reperfusion therapy in the setting of AMICS. Unfortunately, little progress has been made on improving survival with subsequent therapies, including intra-aortic balloon pump counter-pulsation (IABP). This lack of progress is worrisome since the incidence of AMICS appears to be increasing.
With the FDA approval of Impella (Abiomed, Danvers, MA) in AMICS, a powerful new tool has become available for hemodynamic support. Impella is a transcatheter axial flow pump, delivered percutaneous, with the ability to provide 2.5 to 4.0 liters/minute of forward flow. The device should provide sufficient forward cardiac flow to support vital organs in the majority of patients who present with AMICS. Since Impella is the only percutaneous temporary ventricular support device approved as safe and effective for use in AMICS, the use of the device has steadily grown. Unfortunately, there is little data available to providers as to the best practice patterns associated with the delivery and use of Impella in AMICS.
Using the most up-to-date research, a treatment algorithm for AMICS was developed and subsequently implemented as a quality improvement initiative throughout southeast Michigan. Patient information was gathered by each of the sites and collected in a retrospective registry. Outcomes and results were shared during quarterly meetings and concluded with a 41-patient pilot feasibility study. This initial pilot study revealed a 76% survival to discharge, a significant improvement compared to prior historical controls.
Given the promising outcomes, leaders from around the world have implemented the treatment algorithm in their local clinical practices with similar results. The investigators have therefore launched the National Cardiogenic Shock Initiative (NCSI). The aim of the NCSI is to bring together experienced centers across the nation who are experts in mechanical reperfusion therapies and have a large experience with the use of mechanical circulatory support devices to systematize care in AMICS.
Our goal is to dramatically decrease the duration patients remain in cardiogenic shock and attempt to decrease total usage and duration of vasopressors and ionotropic agents. The investigators aim to further demonstrate that rapid delivery of mechanical circulatory support will improve hemodynamics, reverse the spiraling neuro-hormonal cascade associated with cardiogenic shock, allowing clinicians to decrease use of vasopressors and inotropic agents and ultimately improve survival.
Healthcare systems that have agreed to adopt the NCSI treatment algorithm are being asked to participate in this prospective registry so that patient outcomes can be analyzed. Participating investigators will be asked to voluntarily provide data from patients completing the treatment algorithm to be included in the NCSI Registry.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||500 participants|
|Target Follow-Up Duration:||1 Year|
|Official Title:||National Cardiogenic Shock Initiative|
|Actual Study Start Date :||May 1, 2016|
|Estimated Primary Completion Date :||May 2021|
|Estimated Study Completion Date :||May 2022|
- Survival to discharge from hospital [ Time Frame: Hospital discharge (average= 11 days) ]All cause mortality at hospital discharge.
- 30 Day Mortality [ Time Frame: 30 days ]All cause mortality at 30 days post-discharge.
- 1 Year Mortality [ Time Frame: 1 year ]All cause mortality at 1 year post-discharge
- Use of MCS Pre-PCI [ Time Frame: At index Cath Lab procedure/PCI (percutaneous coronary intervention) ]Number of patients who receive mechanical circulatory support (MCS) pre-PCI (percutaneous coronary intervention).
- Door to Support Time < 90 Minutes [ Time Frame: At index Cath Lab procedure/PCI (percutaneous coronary intervention) ]Time from patient presentation at hospital to time that MCS (mechanical circulatory support) was started.
- Establish TIMI III Flow [ Time Frame: At index Cath Lab procedure/PCI (percutaneous coronary intervention) ]Establishment of TIMI III (thrombolysis in myocardial infarction) coronary blood flow during index PCI (percutaneous coronary intervention) in culprit lesions.
- Wean off Vasopressors & Inotropes [ Time Frame: At index PCI (percutaneous coronary intervention), 12-hours post-PCI, 24-hours post-PCI ]Ability to wean off vasopressor & inotropic medication use in patients being treated with early MCS (mechanical circulatory support) during treatment for AMICS (acute myocardial infarction with cardiogenic shock).
- Maintain CPO >0.6 Watts [ Time Frame: At index PCI (percutaneous coronary intervention), 12-hours post-PCI, 24-hours post-PCI ]Ability to maintain a cardiac power output (CPO) measurement of > 0.6 watts.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03677180
|Contact: Babar Basir, DO||313-916-8708||NationalCSI@hfhs.org|
|Contact: Michael Hacala||313-916-8708||NationalCSI@hfhs.org|
|Principal Investigator:||William W O'Neill, MD||Henry Ford Health System|
|Study Director:||Babar Basir, DO||Henry Ford Health System|