Heart Disease Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have had a heart attack that started less than 36 hours before arriving at the cardiac catheterisation lab, confirmed by heart tracing (ECG) and/or blood tests showing a specific type of heart attack (STEMI, STEMI equivalent, new left bundle branch block, or NSTEMI with blocked artery evidence on imaging)
• People diagnosed with cardiogenic shock (when the heart cannot pump enough blood to meet the body's needs), confirmed by at least two of the following: high lactate levels or low oxygen in the blood, very low blood pressure or needing medications to keep blood pressure stable, or heart pumping measurements below certain thresholds
• People whose cardiogenic shock developed either before the heart procedure (within 24 hours of shock starting) or within 12 hours after the heart procedure began
• People who received an Impella CP device (a small heart pump) as their first mechanical heart support device for cardiogenic shock
• People aged 18 years or older
• For participants in Europe: written consent provided by the person, their legal representative, or an independent physician

Who may not be able to join:

• People who have a known medical reason that makes the Impella CP device unsafe for them, such as a blood clot in the left heart chamber, a mechanical heart valve, a severely narrowed aortic valve, significant aortic valve leakage, severe artery disease that blocks device placement, a hole between heart chambers, significant right heart failure, heart wall rupture, fluid around the heart, or combined heart and breathing failure
• People whose shock is mainly caused by something other than the left side of the heart failing — for example, right heart attack, severe fluid loss, allergic reaction, bleeding, infection, heart muscle inflammation, blood clot in the lungs, collapsed lung, or abnormal heart rhythms as the main cause
• People whose heart attack has caused specific structural complications such as a tear in the heart wall, a hole between the heart chambers, or a torn heart valve causing sudden severe leakage
• People whose blocked artery was accidentally punctured during the heart procedure
• People who already have another mechanical heart support device in place, including a balloon pump, or who had the Impella CP inserted before being transferred to the main cardiac centre
• People with an acute or existing tear in the main artery (aortic dissection)
• People who had a heart procedure for this same heart attack at a different hospital beforehand
• People who received clot-dissolving medication for this same heart attack
• People who are not responding to verbal commands after a cardiac arrest (inside or outside hospital), which may indicate a lack of oxygen to the brain (specific rules apply depending on whether the person is on a breathing machine — confirm with trial site)
• People with an active heart infection (infective endocarditis)
• People with another serious illness where life expectancy is less than one year (not counting the cardiogenic shock itself)
• People currently enrolled in, or still in follow-up for, another clinical trial of an unapproved drug or device that has not yet reached its main study endpoint

Important: Always verify eligibility with the trial site directly before applying.