The RECOVER IV Trial is studying how to treat patients with heart attacks who develop heart shock. The study will be conducted over the next 5 years at 50 hospitals in North America and Europe. You can find out if this study is taking place in a community near you here. Please use this website to learn more about this study.
Thank you, The RECOVER IV Team
What is heart shock?
Heart shock happens when the heart is not pumping enough blood to the rest of the body. This is a medical emergency that requires immediate treatment. Treatment needs to start within one hour of hospital arrival. Today, treatment of a heart attack with shock begins by quickly inserting a long thin tube through a blood vessel in the arm or leg to unblock the artery.
Sometimes, doctors also use a temporary heart pump to help improve blood flow to the body and to allow the heart to rest. A heart pump is placed in the heart through blood vessels via another long tube. Some doctors use a heart pump with other standard treatments for heart shock and others do not.
Why is this study being done?
About half of patients with heart shock die before leaving the hospital. Despite current treatment, the best strategy to improve survival from heart shock is unknown. This study is being done to learn if using a temporary heart pump helps patients with heart shock recover better compared to other treatments.
What is the study device being studied?
The temporary heart pump being studied is called Impella CP®. This pump has been approved by the US Food and Drug Administration (FDA) for use in patients with heart shock.
Who will be enrolled in the study?
We will enroll eligible adults between the ages of 18 – 90 who come to a participating hospital with heart attack and shock.
Half of participants will receive standard treatment for heart shock with the Impella CP heart pump. The other half of participants will receive standard treatment for heart shock without the Impella CP heart pump. Those who receive the heart pump will have it placed in their heart for at least 24 hours, It will then be removed when their doctors think it is appropriate.
Patients may be enrolled without their consent
Normally, doctors ask their patients if they want to participate in a research study. When heart shock happens the heart does not pump enough blood to the rest of the body, and a patient may become confused. Patients may be too sick to make decisions about a research study. In addition, legal representatives or family members are not always around to make decisions for a patient. In these circumstances, patients may be enrolled in the study without their consent. This is called “Exception from Informed Consent” (EFIC).
Community engagement
In planning for this study, we are engaging with communities and providing information about this research. We are talking with patient advisors to improve communications and gathering feedback about the study using social media, community meetings, informational flyers at local clinics, and hosting focus groups. We are also sharing information about this study through newspaper and radio ads and giving out brochures in the community.
Tell us what you think!
Before the study begins, we want to hear what you think. We appreciate your feedback!
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You may opt out of this study
We are providing community members with a way to opt out of the study ahead of time, should you have heart shock and be eligible to be enrolled. You can choose to opt out of the study here: