Cardiogenic ShockIMPELLA-PLTNCT06487091
Platelet Function and Impella Support
An observational study of Cardiogenic Shock and Cardiac Arrest, run by Università Vita-Salute San Raffaele at 2 sites in Italy.
Trial summary
Mechanical circulatory support (MCS) with the Impella microaxial pump in the setting of cardiogenic shock/cardiac arrest (CS/CA) is accompanied by substantial risk of life-threatening complications, including hemolysis, thrombotic and bleeding events. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cardiogenic Shock, Cardiac Arrest, Mechanical Circulatory Support
- What is being tested?
- Analysis of platelet function
- How many people
- 30 participants
- Where
- 2 sitesItaly
- Study dates
- 24 Feb 2025to 10 Apr 2026
- How long will I take part?
- 3 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: CS/CA patients who receive temporary mechanical circulatory support with an Impella device
Who may be able to join
- Patients >18yrs-old and <75yrs-old
- Cardiogenic shock SCAI class C-D-E
- primary tMCS with an Impella device (all Impella pumps)
- Informed consent
Who cannot join
- Patients <18yrs-old or >75yrs-old
- Refusal to participate to the study
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
IRCCS San Raffaele Hospital
Milan, 20132
Università Vita Salute San Raffaele
Milan, 20132
About this study
Official title: Analysis of Platelet Function During Impella Support
Mechanical circulatory support (MCS) with the Impella microaxial pump in the setting of cardiogenic shock/cardiac arrest (CS/CA) is accompanied by substantial risk of life-threatening complications, including hemolysis, thrombotic and bleeding events.
Previous studies in patients on durable MCS suggest that device-induced platelet dysfunction plays a major contributory role in the development of such events and that selected markers of platelet function have the potential to stratify patients according to an elevated risk of adverse events. To date, the potential clinical utility of markers of altered platelet function in patients supported with an Impella pump is unexplored.
Read more
The proposed study will analyze changes in platelet function in the setting of Impella support (primary aim) and possibly identify a platelet function "profile" indicative of patients at high-risk to develop adverse events (secondary aim).
The study is a prospective observational study. Changes in the expression levels of markers of both platelet activation and aggregation in patients supported with an Impella pump will be measured. Data will be longitudinally measured: pre-implant (before Impella implantation) and then after 24, 48 and 72h of Impella support. Markers that will be analyzed include surface platelet receptors and platelet microRNAs. Experimental data will be correlated with clinical outcomes, including the occurrence of adverse events.
This study will provide mechanistic insights into the effect of Impella support on the protein and miRNA expression of platelets. The intention is to get a better understanding of distinct pathways of platelet function related to Impella support and their relationship to adverse events. Our data might open the perspective for the future clinical use of markers of platelet function to enhance the early recognition of patients at high risk of developing an adverse event and the definition of novel, personalized therapeutic strategies targeted to platelet biology to prevent their occurrence.
Read the detailed description
STUDY DESIGN AND MAIN OBJECTIVE Prospective observational study to evaluate changes in the expression levels of markers of platelet function (activation and aggregation capacity) in CS/CA patients who receive an Impella device for temporary mechanical circulatory support
HYPOTHESIS
- progressive change of platelet function occurs over the course of Impella support driven by shear forces exerted by the pump on recirculating blood
- markers of changes in platelet function can be identified at the protein and nuclear level in platelet samples extracted form patients supported with an Impella pump
- specific trends of the changes of the expression levels of markers of platelet function might allow identifying patients at higher risk of developing a thrombotic/hemorrhagic complication
- the expression levels of markers of platelet function are indeed altered in patients even before the clinical manifestation of the event
METHODOLOGY The markers that will be analyzed have been selected according to recent studies showing
- significant changes in their expression levels driven by durable MCS devices
- their potential to identify patients at high risk of developing adverse events
- their association with coagulation/hemostatic disorders and hemolysis and include:
- platelet receptors GPIba, GPIIb/IIIa, and GPVI [1-4].
- platelet microRNA miR-20b-5p, miR-25-3p, miR-126-5p, miR-451a, miR-320a, miR-223-3p, miR-144-rp, miR-151a-3p, and miR-454-3p [5]. The expression levels of these microRNAs will be measured in both PRP and PPP samples, to confirm their actual expression by platelets.
Data will be measured
- pre-implant (i.e., immediately prior to Impella implantation), to evaluate the patient-specific baseline profile, and then following
- 24 hours, 48 hours, and 72 hours of Impella support. This way it will possible to quantify longitudinal changes in the levels of expression of the selected markers over the course of Impella support (vs. baseline).
Data will be also measured during the acute phase of any of the following adverse events that will occur during Impella support (not limited to 72 hours):
- thrombosis (of the patient - any site - and of the pump)
- ischemic/hemorrhagic stroke
- any surgical or non-surgical bleeding
- hemolysis Adverse events will be defined according to most recent criteria [6-8].
Furthermore, inferences of any change in the anticaogulation regimen that may occur over the course of Impella support (not limited to 72 hours) will be evaluated: to this aim, markers of platelet function will be analyzed 12 hours following any change in the anticoagulation regimen.
Experimental data will be correlated with clinical outcomes, including the occurrence of adverse events, to possibly identify an "event-related platelet function profile" characteristics of the sub-group of patients that will develop adverse events. The occurrence of adverse events will be continuously recorded over the whole duration of Impella support.
TREATMENT PROCEDURE To measure the expression levels of the selected markers of platelet function, platelet samples will be isolated from patients' blood (10-mL volume) via standard laboratory techniques. The expression levels of the analyzed markers will be measured via quantitative real-time polymerase chain reaction and protein quantitation/function assay, such as enzyme-linked immunosorbent assay.
- Being tested
- Analysis of platelet function
- Keywords
- Cardiogenic Shock, Cardiac Arrest, Mechanical Circulatory Support, Impella, Platelet Function, Bleeding, Thrombosis, Hemolyisis, platelet microRNA
- Medical subject headings
- Shock, Cardiogenic, Heart Arrest, Hemorrhage, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analysis of platelet functionDiagnostic test
Blood withdrawal, platelet separation and analysis of the expression levels of markers of platelet function
| Study group | Role | What they receive |
|---|---|---|
| patients on Impella support | CS/CA patients that receive primary temporary mechanical circulatory support with an Impella device Receives: Diagnostic Test: Analysis of platelet function |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression levels of platelet surface markers of activation and aggregation and platelet microRNAs in patients on Impella support
Changes (measured as percentage variation) in the expression levels of platelet surface markers of activation and aggregation (GPIba, GPIIb/IIIa, and GPVI) and platelet microRNA (miR-20b-5p, miR-25-3p, miR-126-5p, miR-451a, miR-320a, miR-223-3p, miR-144-rp, miR-151a-3p, and miR-454-3p) during tMCS with an Impella device (all Impella pumps)
Measured: baseline (prior to Impella implantation) vs. 24 hours, 48 hours and 72 hours of Impella support
Secondary outcomes (2)
Expression levels of platelet surface markers of activation and aggregation and platelet microRNAs in the acute phase of an adverse event (hemolysis, thrombosis, bleeding). Adverse events will be determined according to [6-8]
Expression levels of platelet surface markers of activation and aggregation (GPIba, GPIIb/IIIa, and GPVI) and platelet microRNA (miR-20b-5p, miR-25-3p, miR-126-5p, miR-451a, miR-320a, miR-223-3p, miR-144-rp, miR-151a-3p, and miR-454-3p) measured following the occurrence of an adverse event (hemolysis, thrombosis, bleeding)
Measured: immediately after any adverse event, anticipated average 30 days
Expression levels of platelet surface markers of activation and aggregation and platelet microRNAs after any change in the antithrombotic regimen
Expression levels of platelet surface markers of activation and aggregation (GPIba, GPIIb/IIIa, and GPVI) and platelet microRNA (miR-20b-5p, miR-25-3p, miR-126-5p, miR-451a, miR-320a, miR-223-3p, miR-144-rp, miR-151a-3p, and miR-454-3p) measured following any change in the antithrombotic regimen (lower dose and/or withdrawal of anticoagulant/antiplatelet drugs)
Measured: 12 hours after any change in the antithrombotic regimen
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start24 Feb 2025
- Primary completion10 Apr 2026
- Study completion10 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Cardiogenic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- Università Vita-Salute San Raffaele
- Sponsor type
- University, hospital or other
- Collaborators
- Abiomed Inc.
- Responsible party
- Principal investigator, Filippo Consolo, IRCCS Ospedale San Raffaele
- Investigators
- Filippo Consolo, PhD, Study chair, Università Vita-Salute San RaffaeleMara Scandroglio, MD, Principal investigator, Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06487091
- Sponsor's protocol ID
- IMPELLA-PLT
- Acronym
- IMPELLA-PLT
- Status last verified
- Apr 2026
- First submitted
- 31 May 2024
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Chen Z, Mondal NK, Ding J, Gao J, Griffith BP, Wu ZJ. Shear-induced platelet receptor shedding by non-physiological high shear stress with short exposure time: glycoprotein Ibalpha and glycoprotein VI. Thromb Res. 2015 Apr;135(4):692-8. doi: 10.1016/j.thromres.2015.01.030. Epub 2015 Feb 7.
PubMed 25677981Klaeske K, Dieterlen MT, Eifert S, Scholz U, Garbade J, Jawad K, Sieg F, Borger MA, Meyer AL. Device-induced platelet dysfunction in patients after left ventricular assist device implantation. J Thromb Haemost. 2021 May;19(5):1331-1341. doi: 10.1111/jth.15279. Epub 2021 Mar 28.
PubMed 33636040Arias K, Sun W, Wang S, Sorensen EN, Feller E, Kaczorowski D, Griffith B, Wu ZJ. Acquired platelet defects are responsible for nonsurgical bleeding in left ventricular assist device recipients. Artif Organs. 2022 Nov;46(11):2244-2256. doi: 10.1111/aor.14319. Epub 2022 May 30.
PubMed 35596611Klaeske K, Meyer AL, Saeed D, Eifert S, Jawad K, Sieg F, Haunschild J, Borger MA, Dieterlen MT. Decreased Platelet Specific Receptor Expression of P-Selectin and GPIIb/IIIa Predict Future Non-Surgical Bleeding in Patients after Left Ventricular Assist Device Implantation. Int J Mol Sci. 2022 Sep 6;23(18):10252. doi: 10.3390/ijms231810252.
PubMed 36142161Lombardi M, Bonora M, Baldetti L, Pieri M, Scandroglio AM, Landoni G, Zangrillo A, Foglieni C, Consolo F. Left ventricular assist devices promote changes in the expression levels of platelet microRNAs. Front Cardiovasc Med. 2023 Jun 15;10:1178556. doi: 10.3389/fcvm.2023.1178556. eCollection 2023.
PubMed 37396581Bernhardt AM, Copeland H, Deswal A, Gluck J, Givertz MM; Chairs:; Co-Chairs:; Contributing Writers:; Chair:; Co-Chair:; Contributing Writers:; Chair:; Co-Chairs:; Contributing Writers:; Chair:; Co-Chair:; Contributing Writers:. The International Society for Heart and Lung Transplantation/Heart Failure Society of America Guideline on Acute Mechanical Circulatory Support. J Heart Lung Transplant. 2023 Apr;42(4):e1-e64. doi: 10.1016/j.healun.2022.10.028. Epub 2023 Feb 6. No abstract available.
PubMed 36805198Garcia-Garcia HM, McFadden EP, Farb A, Mehran R, Stone GW, Spertus J, Onuma Y, Morel MA, van Es GA, Zuckerman B, Fearon WF, Taggart D, Kappetein AP, Krucoff MW, Vranckx P, Windecker S, Cutlip D, Serruys PW; Academic Research Consortium. Standardized End Point Definitions for Coronary Intervention Trials: The Academic Research Consortium-2 Consensus Document. Circulation. 2018 Jun 12;137(24):2635-2650. doi: 10.1161/CIRCULATIONAHA.117.029289.
PubMed 29891620Kormos RL, Antonides CFJ, Goldstein DJ, Cowger JA, Starling RC, Kirklin JK, Rame JE, Rosenthal D, Mooney ML, Caliskan K, Messe SR, Teuteberg JJ, Mohacsi P, Slaughter MS, Potapov EV, Rao V, Schima H, Stehlik J, Joseph S, Koenig SC, Pagani FD. Updated definitions of adverse events for trials and registries of mechanical circulatory support: A consensus statement of the mechanical circulatory support academic research consortium. J Heart Lung Transplant. 2020 Aug;39(8):735-750. doi: 10.1016/j.healun.2020.03.010. Epub 2020 Apr 18. No abstract available.
PubMed 32386998
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Platelet Function During Impella Support
- ClinicalTrials.gov ID
- NCT06487091
- Acronym / sponsor ID
- IMPELLA-PLT / IMPELLA-PLT
- Keywords
- Cardiogenic Shock, Cardiac Arrest, Mechanical Circulatory Support, Impella, Platelet Function, Bleeding, Thrombosis, Hemolyisis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Università Vita-Salute San RaffaeleUniversity, hospital or other
- Collaborators
- Abiomed Inc.
- Study start
- 24 Feb 2025 (actual)
- Primary completion
- 10 Apr 2026 (actual)
- Study completion
- 10 Apr 2026 (actual)
- First posted
- 5 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Mechanical circulatory support (MCS) with the Impella microaxial pump in the setting of cardiogenic shock/cardiac arrest (CS/CA) is accompanied by substantial risk of life-threatening complications, including hemolysis, thrombotic and bleeding events.
Previous studies in patients on durable MCS suggest that device-induced platelet dysfunction plays a major contributory role in the development of such events and that selected markers of platelet function have the potential to stratify patients according to an elevated risk of adverse events. To date, the potential clinical utility of markers of altered platelet function in patients supported with an Impella pump is unexplored.
The proposed study will analyze changes in platelet function in the setting of Impella support (primary aim) and possibly identify a platelet function "profile" indicative of patients at high-risk to develop adverse events (secondary aim).
The study is a prospective observational study. Changes in the expression levels of markers of both platelet activation and aggregation in patients supported with an Impella pump will be measured. Data will be longitudinally measured: pre-implant (before Impella implantation) and then after 24, 48 and 72h of Impella support. Markers that will be analyzed include surface platelet receptors and platelet microRNAs. Experimental data will be correlated with clinical outcomes, including the occurrence of adverse events.
This study will provide mechanistic insights into the effect of Impella support on the protein and miRNA expression of platelets. The intention is to get a better understanding of distinct pathways of platelet function related to Impella support and their relationship to adverse events. Our data might open the perspective for the future clinical use of markers of platelet function to enhance the early recognition of patients at high risk of developing an adverse event and the definition of novel, personalized therapeutic strategies targeted to platelet biology to prevent their occurrence.
Detailed description
STUDY DESIGN AND MAIN OBJECTIVE Prospective observational study to evaluate changes in the expression levels of markers of platelet function (activation and aggregation capacity) in CS/CA patients who receive an Impella device for temporary mechanical circulatory support
HYPOTHESIS
- progressive change of platelet function occurs over the course of Impella support driven by shear forces exerted by the pump on recirculating blood
- markers of changes in platelet function can be identified at the protein and nuclear level in platelet samples extracted form patients supported with an Impella pump
- specific trends of the changes of the expression levels of markers of platelet function might allow identifying patients at higher risk of developing a thrombotic/hemorrhagic complication
- the expression levels of markers of platelet function are indeed altered in patients even before the clinical manifestation of the event
METHODOLOGY The markers that will be analyzed have been selected according to recent studies showing
- significant changes in their expression levels driven by durable MCS devices
- their potential to identify patients at high risk of developing adverse events
- their association with coagulation/hemostatic disorders and hemolysis and include:
- platelet receptors GPIba, GPIIb/IIIa, and GPVI [1-4].
- platelet microRNA miR-20b-5p, miR-25-3p, miR-126-5p, miR-451a, miR-320a, miR-223-3p, miR-144-rp, miR-151a-3p, and miR-454-3p [5]. The expression levels of these microRNAs will be measured in both PRP and PPP samples, to confirm their actual expression by platelets.
Data will be measured
- pre-implant (i.e., immediately prior to Impella implantation), to evaluate the patient-specific baseline profile, and then following
- 24 hours, 48 hours, and 72 hours of Impella support. This way it will possible to quantify longitudinal changes in the levels of expression of the selected markers over the course of Impella support (vs. baseline).
Data will be also measured during the acute phase of any of the following adverse events that will occur during Impella support (not limited to 72 hours):
- thrombosis (of the patient - any site - and of the pump)
- ischemic/hemorrhagic stroke
- any surgical or non-surgical bleeding
- hemolysis Adverse events will be defined according to most recent criteria [6-8].
Furthermore, inferences of any change in the anticaogulation regimen that may occur over the course of Impella support (not limited to 72 hours) will be evaluated: to this aim, markers of platelet function will be analyzed 12 hours following any change in the anticoagulation regimen.
Experimental data will be correlated with clinical outcomes, including the occurrence of adverse events, to possibly identify an "event-related platelet function profile" characteristics of the sub-group of patients that will develop adverse events. The occurrence of adverse events will be continuously recorded over the whole duration of Impella support.
TREATMENT PROCEDURE To measure the expression levels of the selected markers of platelet function, platelet samples will be isolated from patients' blood (10-mL volume) via standard laboratory techniques. The expression levels of the analyzed markers will be measured via quantitative real-time polymerase chain reaction and protein quantitation/function assay, such as enzyme-linked immunosorbent assay.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients on Impella support | – | Diagnostic Test: Analysis of platelet functionCS/CA patients that receive primary temporary mechanical circulatory support with an Impella device |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- CS/CA patients who receive temporary mechanical circulatory support with an Impella device
Key inclusion criteria (4 listed)
- Patients >18yrs-old and <75yrs-old
- Cardiogenic shock SCAI class C-D-E
- primary tMCS with an Impella device (all Impella pumps)
- Informed consent
Key exclusion criteria (2 listed)
- Patients <18yrs-old or >75yrs-old
- Refusal to participate to the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Analysis of platelet functionBlood withdrawal, platelet separation and analysis of the expression levels of markers of platelet function | Diagnostic test | patients on Impella support |
Primary outcome
Expression levels of platelet surface markers of activation and aggregation and platelet microRNAs in patients on Impella support
Time frame: baseline (prior to Impella implantation) vs. 24 hours, 48 hours and 72 hours of Impella support
Changes (measured as percentage variation) in the expression levels of platelet surface markers of activation and aggregation (GPIba, GPIIb/IIIa, and GPVI) and platelet microRNA (miR-20b-5p, miR-25-3p, miR-126-5p, miR-451a, miR-320a, miR-223-3p, miR-144-rp, miR-151a-3p, and miR-454-3p) during tMCS with an Impella device (all Impella pumps)
2 secondary outcomes
Expression levels of platelet surface markers of activation and aggregation and platelet microRNAs in the acute phase of an adverse event (hemolysis, thrombosis, bleeding). Adverse events will be determined according to [6-8]
Time frame: immediately after any adverse event, anticipated average 30 days
Expression levels of platelet surface markers of activation and aggregation and platelet microRNAs after any change in the antithrombotic regimen
Time frame: 12 hours after any change in the antithrombotic regimen
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Background: PubMed 25677981Chen Z, Mondal NK, Ding J, Gao J, Griffith BP, Wu ZJ. Shear-induced platelet receptor shedding by non-physiological high shear stress with short exposure time: glycoprotein Ibalpha and glycoprotein VI. Thromb Res. 2015 Apr;135(4):692-8. doi: 10.1016/j.thromres.2015.01.030. Epub 2015 Feb 7.
- Background: PubMed 33636040Klaeske K, Dieterlen MT, Eifert S, Scholz U, Garbade J, Jawad K, Sieg F, Borger MA, Meyer AL. Device-induced platelet dysfunction in patients after left ventricular assist device implantation. J Thromb Haemost. 2021 May;19(5):1331-1341. doi: 10.1111/jth.15279. Epub 2021 Mar 28.
- Background: PubMed 35596611Arias K, Sun W, Wang S, Sorensen EN, Feller E, Kaczorowski D, Griffith B, Wu ZJ. Acquired platelet defects are responsible for nonsurgical bleeding in left ventricular assist device recipients. Artif Organs. 2022 Nov;46(11):2244-2256. doi: 10.1111/aor.14319. Epub 2022 May 30.
- Background: PubMed 36142161Klaeske K, Meyer AL, Saeed D, Eifert S, Jawad K, Sieg F, Haunschild J, Borger MA, Dieterlen MT. Decreased Platelet Specific Receptor Expression of P-Selectin and GPIIb/IIIa Predict Future Non-Surgical Bleeding in Patients after Left Ventricular Assist Device Implantation. Int J Mol Sci. 2022 Sep 6;23(18):10252. doi: 10.3390/ijms231810252.
- Background: PubMed 37396581Lombardi M, Bonora M, Baldetti L, Pieri M, Scandroglio AM, Landoni G, Zangrillo A, Foglieni C, Consolo F. Left ventricular assist devices promote changes in the expression levels of platelet microRNAs. Front Cardiovasc Med. 2023 Jun 15;10:1178556. doi: 10.3389/fcvm.2023.1178556. eCollection 2023.
- Background: PubMed 36805198Bernhardt AM, Copeland H, Deswal A, Gluck J, Givertz MM; Chairs:; Co-Chairs:; Contributing Writers:; Chair:; Co-Chair:; Contributing Writers:; Chair:; Co-Chairs:; Contributing Writers:; Chair:; Co-Chair:; Contributing Writers:. The International Society for Heart and Lung Transplantation/Heart Failure Society of America Guideline on Acute Mechanical Circulatory Support. J Heart Lung Transplant. 2023 Apr;42(4):e1-e64. doi: 10.1016/j.healun.2022.10.028. Epub 2023 Feb 6. No abstract available.
- Background: PubMed 29891620Garcia-Garcia HM, McFadden EP, Farb A, Mehran R, Stone GW, Spertus J, Onuma Y, Morel MA, van Es GA, Zuckerman B, Fearon WF, Taggart D, Kappetein AP, Krucoff MW, Vranckx P, Windecker S, Cutlip D, Serruys PW; Academic Research Consortium. Standardized End Point Definitions for Coronary Intervention Trials: The Academic Research Consortium-2 Consensus Document. Circulation. 2018 Jun 12;137(24):2635-2650. doi: 10.1161/CIRCULATIONAHA.117.029289.
- Background: PubMed 32386998Kormos RL, Antonides CFJ, Goldstein DJ, Cowger JA, Starling RC, Kirklin JK, Rame JE, Rosenthal D, Mooney ML, Caliskan K, Messe SR, Teuteberg JJ, Mohacsi P, Slaughter MS, Potapov EV, Rao V, Schima H, Stehlik J, Joseph S, Koenig SC, Pagani FD. Updated definitions of adverse events for trials and registries of mechanical circulatory support: A consensus statement of the mechanical circulatory support academic research consortium. J Heart Lung Transplant. 2020 Aug;39(8):735-750. doi: 10.1016/j.healun.2020.03.010. Epub 2020 Apr 18. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Filippo Consolo, PhD study chair
Università Vita-Salute San Raffaele
Mara Scandroglio, MD principal investigator
Ospedale San Raffaele
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiogenic Shock and Cardiac Arrest, run by Università Vita-Salute San Raffaele at 2 sites in Italy.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expression levels of platelet surface markers of activation and aggregation and platelet microRNAs in patients on Impella support (time frame: baseline (prior to Impella implantation) vs. 24 hours, 48 hours and 72 hours of Impella support). 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 NCT06487091, which also lists 8 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 5 May 2026.