| NCT ID | NCT06644963 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Montpellier |
| Condition | Cardiogenic Shock |
| Study Type | OBSERVATIONAL |
| Enrollment | 800 participants |
| Start Date | 2010-01-01 |
| Primary Completion | 2023-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 800 participants in total. It began in 2010-01-01 with a primary completion date of 2023-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Myocardial infarction complicated by cardiogenic shock (AMICS) is associated with high morbidity and mortality, and devices like Impella® CP and Impella 5.0-5.5 are often used for hemodynamic support, either alone or combined with veno-arterial ECMO (ECMELLA). While recent studies suggest improved survival with Impella® in cardiogenic shock, complications remain common, particularly due to deep arterial access and the need for anticoagulation. Hemocompatibility-related adverse events (HRAEs) such as ischemia, bleeding (44%), hemolysis (32%), and stroke (13%) frequently occur. Achieving hemocompatibility between the patient's blood and the device is challenging, as pump flow, anticoagulation, and patient factors contribute to both thrombotic and hemorrhagic complications. Despite advances, further research is required to better understand and reduce these risks in clinical practice.
Eligibility Criteria
Inclusion Criteria: * Adult patients admitted for cardiogenic shock supported by Impella (5, 5.5 or CP) between January 1, 2010, and December 31, 2022 (as an isolated circulatory support or combined with others Temporary Mechanical Circulatory Support) Exclusion Criteria: * Absence of Impella * Impella 2.5 * Impella RP (right)
Contact & Investigator
Aurore UGHETTO, MD
PRINCIPAL INVESTIGATOR
Montpellier University Hospital
Frequently Asked Questions
Who can join the NCT06644963 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cardiogenic Shock. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06644963 currently recruiting?
Yes, NCT06644963 is actively recruiting participants. Contact the research team at a-ughetto@chu-montpellier.fr for enrollment information.
Where is the NCT06644963 trial being conducted?
This trial is being conducted at Montpellier, France.
Who is sponsoring the NCT06644963 clinical trial?
NCT06644963 is sponsored by University Hospital, Montpellier. The principal investigator is Aurore UGHETTO, MD at Montpellier University Hospital. The trial plans to enroll 800 participants.