Pilot Italian Cardiogenic Shock Initiative

NCT06475456 | Recruiting DMC

• 1 other identifier: I-CSI-IT V1.0 07 May 2024
• Study Type: observational
• Target: 786
• Locations: 1 country
• Sites: 16

Brief Summary

Study Objective To evaluate the impact on 30-day mortality of the adoption of a dedicated cardiogenic shock protocol designed to improve communication and collaboration among centres to timely refer Cardiogenic Shock (CS) patients from spoke to hub centres in Turin and Milan metropolitan Area. Study Design A multicentre, observational, study, consisting of

• retrospective cohort including anonymous data from electronic health records of patients admitted with acute myocardial infarction complicated by cardiogenic shock (AMICS) SCAI class B-D, from Jan 2016 until Dec 2019
• prospective cohort including all consecutive patients admitted for AMICS SCAI class B-D in the study centres Study Population and Centres 768 patients admitted in spoke hospitals for AMICS: 384 in each study cohort. Four centres - two in Milan metropolitan Area and two in Turin - will serve as hub centres, each one receiving CS patients from three referring spoke centres. In total, 16 centres will be involved in the study. Follow-up period Up to 30 days from hospital admission Primary Endpoint The primary endpoint will be the short-term mortality defined as inhospital or 30-day mortality. Secondary Endpoints
• In-hospital or 30-day incidence of:
• stroke, (fatal or non-fatal) or TIA
• bleedings (BARC classification ≥3),
• renal replacement therapy (CVVH / new onset of dialysis)
• vascular complications (all complication needing intervention),
• non-fatal myocardial infarction
• Door-to-support time,
• Onset of symptoms to support time Inclusion criteria Prospective cohort
• For conscious patients, signed and dated informed consent and consent to the processing of personal data
• For unconscious patients, informed consent signed and dated by the legal representative, or a proxy or a relative. The consent will be presented to the patient as soon the health conditions will improve.
• Aging more than 18 years
• Patients admitted within 24h from the diagnosis of AMICS and SCAI SHOCK classification B to D. CS will be defined as:
• Systolic blood pressure (SBP) \< 90 mmHg or mean arterial pressure (MAP) \< 60 mmHg, after an appropriate fluid challenge if there is no sign of overt fluid overload, OR need of vasoactive agents to maintain SBP \> 90 mmHg or MAP \> 60 mmHg, OR need of mechanical cardiac support (MCS);
• At least one of the following criteria/signs of overt hypoperfusion: mixed venous oxygen saturation \< 60% arterial lactates \> 2 mmol/L; oliguria \< 0.5 ml/Kg/h for at least 6 hours.
• CS SCAI B-C-D following an acute myocardial infarction (AMICS) or acute decompensation of heart failure (ADHFCS) Exclusion criteria

Conditions

Cardiogenic Shock

Keywords

cardiogenic shock; SPOKE-HUB

Outcome Measures

Primary Outcomes (1)

• Mortality.

  short-term mortality defined as inhospital or 30-day mortality.

  30-days

Secondary Outcomes (7)

• Stroke, (fatal or non-fatal) or TIA

  30-days

• Bleedings (BARC classification ≥3),

  30-days

• Renal replacement therapy

  30-days

• Vascular complications

  30-days

• Non-fatal myocardial infarction

  30-days

Study Arms (2)

Pre-Protocol Cohort

Patients enrolled retrospectively between 2016 and 2019

Post-protocol Cohort

Patients enrolled prospectively between 2024 and 2026

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients presenting with cardiogenic shock SCAI B to D as defined in inclusion criteria

You may qualify if:

• All subjects participating in this clinical trial must meet the following criteria:
• Prospective cohort
• For conscious patients, signed and dated informed consent and consent to the processing of personal data
• For unconscious patients, informed consent signed and dated by the legal representative, or a proxy or a relative. The consent will be presented to the patient as soon the health conditions will improve. Aging ≥18
• CS will be defined as:
• Systolic blood pressure (SBP) \&lt;90 mmHg or mean arterial pressure (MAP) \&lt;60 mmHg, after an appropriate fluid challenge if there is no sign of overt fluid overload, OR need of vasoactive agents to maintain SBP \&gt; 90 mmHg or MAP \&gt; 60 mmHg, OR need of MCS;
• At least one of the following criteria/signs of overt hypoperfusion: mixed venous oxygen saturation \&lt;60%; arterial lactates \&gt; 2 mmol/L; oliguria \&lt; 0.5 ml/Kg/h for at least 6 hours.
• CS following an acute myocardial infarction (AMICS) or acute decompensation of heart failure (ADHF-CS)

You may not qualify if:

• Patients will be excluded if any of the following conditions apply:
• Cardiac arrest with no quantifiable or longer than 10 minutes "no-flow" time or with refractory cardiac arrest (as defined by CPR prolonging for more than 20')
• Absolute contraindication to support devices.
• Age greater than 75-year-old
• Life expectancy \&lt; 1 year due to other reason than cardiogenic shock.

Sponsors & Collaborators

• Fondazione GISE Onlus: lead
• Mediolanum Cardio Research: collaborator
• San Raffaele University Hospital, Italy: collaborator

Study Sites (16)

Ospedale di Chivasso

Chivasso, Italy

RECRUITING

ASL TO4 Ospedale di Ciriè

Cirié, Italy

RECRUITING

Ospedale Pio XI di Desio

Desio, Italy

RECRUITING

ASL Torino 4 Ospedale di Ivrea

Ivrea, Italy

RECRUITING

ASST Grande Ospedale Metropolitano Niguarda

Milan, Italy

RECRUITING

ASST Nord Milano

Milan, Italy

RECRUITING

IRCCS San Raffaele

Milan, Italy

RECRUITING

Ospedale San Carlo Borromeo

Milan, Italy

RECRUITING

Ospedale San Paolo

Milan, Italy

RECRUITING

ASL TO5 Ospedale Santa Croce

Moncalieri, Italy

RECRUITING

Presidio Ospedaliero di Rho

Rho, Italy

RECRUITING

Ospedale Civile SS. Annunziata

Savigliano, Italy

RECRUITING

AOU Città della Salute e della Scienza

Torino, Italy

RECRUITING

Azienda Sanitaria Locale "Città di Torino" Ospedale Maria Vittoria

Torino, Italy

RECRUITING

San Giovanni Bosco, ASL Città di Torino

Turin, Italy

RECRUITING

Ospedale di Vimercate

Vimercate, Italy

RECRUITING

Related Publications (20)

• Tehrani BN, Truesdell AG, Psotka MA, Rosner C, Singh R, Sinha SS, Damluji AA, Batchelor WB. A Standardized and Comprehensive Approach to the Management of Cardiogenic Shock. JACC Heart Fail. 2020 Nov;8(11):879-891. doi: 10.1016/j.jchf.2020.09.005.

  PMID: 33121700 BACKGROUND

• Iannaccone M, Albani S, Giannini F, Colangelo S, Boccuzzi GG, Garbo R, Brilakis ES, D'ascenzo F, de Ferrari GM, Colombo A. Short term outcomes of Impella in cardiogenic shock: A review and meta-analysis of observational studies. Int J Cardiol. 2021 Feb 1;324:44-51. doi: 10.1016/j.ijcard.2020.09.044. Epub 2020 Sep 22.

  PMID: 32971148 BACKGROUND

• Chieffo A, Dudek D, Hassager C, Combes A, Gramegna M, Halvorsen S, Huber K, Kunadian V, Maly J, Moller JE, Pappalardo F, Tarantini G, Tavazzi G, Thiele H, Vandenbriele C, Van Mieghem N, Vranckx P, Werner N, Price S. Joint EAPCI/ACVC expert consensus document on percutaneous ventricular assist devices. EuroIntervention. 2021 Jul 20;17(4):e274-e286. doi: 10.4244/EIJY21M05_01.

  PMID: 34057071 BACKGROUND

• Ibanez B, James S, Agewall S, Antunes MJ, Bucciarelli-Ducci C, Bueno H, Caforio ALP, Crea F, Goudevenos JA, Halvorsen S, Hindricks G, Kastrati A, Lenzen MJ, Prescott E, Roffi M, Valgimigli M, Varenhorst C, Vranckx P, Widimsky P; ESC Scientific Document Group. 2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: The Task Force for the management of acute myocardial infarction in patients presenting with ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J. 2018 Jan 7;39(2):119-177. doi: 10.1093/eurheartj/ehx393. No abstract available.

  PMID: 28886621 BACKGROUND

• Nasu T, Ninomiya R, Koeda Y, Morino Y. Impella device in fulminant myocarditis: Japanese Registry for Percutaneous Ventricular Assist Device (J-PVAD) registry analysis on outcomes and adverse events. Eur Heart J Acute Cardiovasc Care. 2024 Mar 11;13(3):275-283. doi: 10.1093/ehjacc/zuad149.

  PMID: 38048601 BACKGROUND

• Tehrani BN, Sherwood MW, Rosner C, Truesdell AG, Ben Lee S, Damluji AA, Desai M, Desai S, Epps KC, Flanagan MC, Howard E, Ibrahim N, Kennedy J, Moukhachen H, Psotka M, Raja A, Saeed I, Shah P, Singh R, Sinha SS, Tang D, Welch T, Young K, deFilippi CR, Speir A, O'Connor CM, Batchelor WB. A Standardized and Regionalized Network of Care for Cardiogenic Shock. JACC Heart Fail. 2022 Oct;10(10):768-781. doi: 10.1016/j.jchf.2022.04.004. Epub 2022 Jun 8.

  PMID: 36175063 BACKGROUND

• Lu DY, Adelsheimer A, Chan K, Yeo I, Krishnan U, Karas MG, Horn EM, Feldman DN, Sobol I, Goyal P, Bhatt R, Batra S, Sciria CT, Olonoff D, Cheung JW, Kim LK. Impact of hospital transfer to hubs on outcomes of cardiogenic shock in the real world. Eur J Heart Fail. 2021 Nov;23(11):1927-1937. doi: 10.1002/ejhf.2263. Epub 2021 Jun 22.

  PMID: 34114302 BACKGROUND

• Tehrani BN, Truesdell AG, Sherwood MW, Desai S, Tran HA, Epps KC, Singh R, Psotka M, Shah P, Cooper LB, Rosner C, Raja A, Barnett SD, Saulino P, deFilippi CR, Gurbel PA, Murphy CE, O'Connor CM. Standardized Team-Based Care for Cardiogenic Shock. J Am Coll Cardiol. 2019 Apr 9;73(13):1659-1669. doi: 10.1016/j.jacc.2018.12.084.

  PMID: 30947919 BACKGROUND

• Wang JI, Lu DY, Mhs, Feldman DN, McCullough SA, Goyal P, Karas MG, Sobol I, Horn EM, Kim LK, Krishnan U. Outcomes of Hospitalizations for Cardiogenic Shock at Left Ventricular Assist Device Versus Non-Left Ventricular Assist Device Centers. J Am Heart Assoc. 2020 Dec;9(23):e017326. doi: 10.1161/JAHA.120.017326. Epub 2020 Nov 23.

  PMID: 33222608 BACKGROUND

• Becher PM, Gossling A, Schrage B, Twerenbold R, Fluschnik N, Seiffert M, Bernhardt AM, Reichenspurner H, Blankenberg S, Westermann D. Procedural volume and outcomes in patients undergoing VA-ECMO support. Crit Care. 2020 Jun 5;24(1):291. doi: 10.1186/s13054-020-03016-z.

  PMID: 32503646 BACKGROUND

• Samsky M, Krucoff M, Althouse AD, Abraham WT, Adamson P, Aguel F, Bilazarian S, Dangas GD, Gilchrist IC, Henry TD, Hochman JS, Kapur NK, Laschinger J, Masters RG, Michelson E, Morrow DA, Morrow V, Ohman EM, Pina I, Proudfoot AG, Rogers J, Sapirstein J, Senatore F, Stockbridge N, Thiele H, Truesdell AG, Waksman R, Rao S. Clinical and regulatory landscape for cardiogenic shock: A report from the Cardiac Safety Research Consortium ThinkTank on cardiogenic shock. Am Heart J. 2020 Jan;219:1-8. doi: 10.1016/j.ahj.2019.10.006. Epub 2019 Nov 7. No abstract available.

  PMID: 31707323 BACKGROUND

• Iannaccone M, Franchin L, Hanson ID, Boccuzzi G, Basir MB, Truesdell AG, O'Neill W. Timing of impella placement in PCI for acute myocardial infarction complicated by cardiogenic shock: An updated meta-analysis. Int J Cardiol. 2022 Sep 1;362:47-54. doi: 10.1016/j.ijcard.2022.05.011. Epub 2022 May 6.

  PMID: 35533755 BACKGROUND

• Schrage B, Ibrahim K, Loehn T, Werner N, Sinning JM, Pappalardo F, Pieri M, Skurk C, Lauten A, Landmesser U, Westenfeld R, Horn P, Pauschinger M, Eckner D, Twerenbold R, Nordbeck P, Salinger T, Abel P, Empen K, Busch MC, Felix SB, Sieweke JT, Moller JE, Pareek N, Hill J, MacCarthy P, Bergmann MW, Henriques JPS, Mobius-Winkler S, Schulze PC, Ouarrak T, Zeymer U, Schneider S, Blankenberg S, Thiele H, Schafer A, Westermann D. Impella Support for Acute Myocardial Infarction Complicated by Cardiogenic Shock. Circulation. 2019 Mar 5;139(10):1249-1258. doi: 10.1161/CIRCULATIONAHA.118.036614.

  PMID: 30586755 BACKGROUND

• Ouweneel DM, Eriksen E, Sjauw KD, van Dongen IM, Hirsch A, Packer EJ, Vis MM, Wykrzykowska JJ, Koch KT, Baan J, de Winter RJ, Piek JJ, Lagrand WK, de Mol BA, Tijssen JG, Henriques JP. Percutaneous Mechanical Circulatory Support Versus Intra-Aortic Balloon Pump in Cardiogenic Shock After Acute Myocardial Infarction. J Am Coll Cardiol. 2017 Jan 24;69(3):278-287. doi: 10.1016/j.jacc.2016.10.022. Epub 2016 Oct 31.

  PMID: 27810347 BACKGROUND

• O'Gara PT, Kushner FG, Ascheim DD, Casey DE Jr, Chung MK, de Lemos JA, Ettinger SM, Fang JC, Fesmire FM, Franklin BA, Granger CB, Krumholz HM, Linderbaum JA, Morrow DA, Newby LK, Ornato JP, Ou N, Radford MJ, Tamis-Holland JE, Tommaso CL, Tracy CM, Woo YJ, Zhao DX; American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines; American College of Emergency Physicians; Society for Cardiovascular Angiography and Interventions. 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: executive summary: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines: developed in collaboration with the American College of Emergency Physicians and Society for Cardiovascular Angiography and Interventions. Catheter Cardiovasc Interv. 2013 Jul 1;82(1):E1-27. doi: 10.1002/ccd.24776. Epub 2013 Jan 8. No abstract available.

  PMID: 23299937 BACKGROUND

• Hochman JS, Sleeper LA, Webb JG, Sanborn TA, White HD, Talley JD, Buller CE, Jacobs AK, Slater JN, Col J, McKinlay SM, LeJemtel TH. Early revascularization in acute myocardial infarction complicated by cardiogenic shock. SHOCK Investigators. Should We Emergently Revascularize Occluded Coronaries for Cardiogenic Shock. N Engl J Med. 1999 Aug 26;341(9):625-34. doi: 10.1056/NEJM199908263410901.

  PMID: 10460813 BACKGROUND

• Kolte D, Khera S, Aronow WS, Mujib M, Palaniswamy C, Sule S, Jain D, Gotsis W, Ahmed A, Frishman WH, Fonarow GC. Trends in incidence, management, and outcomes of cardiogenic shock complicating ST-elevation myocardial infarction in the United States. J Am Heart Assoc. 2014 Jan 13;3(1):e000590. doi: 10.1161/JAHA.113.000590.

  PMID: 24419737 BACKGROUND

• van Diepen S, Katz JN, Albert NM, Henry TD, Jacobs AK, Kapur NK, Kilic A, Menon V, Ohman EM, Sweitzer NK, Thiele H, Washam JB, Cohen MG; American Heart Association Council on Clinical Cardiology; Council on Cardiovascular and Stroke Nursing; Council on Quality of Care and Outcomes Research; and Mission: Lifeline. Contemporary Management of Cardiogenic Shock: A Scientific Statement From the American Heart Association. Circulation. 2017 Oct 17;136(16):e232-e268. doi: 10.1161/CIR.0000000000000525. Epub 2017 Sep 18.

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• McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2021 Sep 21;42(36):3599-3726. doi: 10.1093/eurheartj/ehab368. No abstract available.

  PMID: 34447992 BACKGROUND

• Naidu SS, Baran DA, Jentzer JC, Hollenberg SM, van Diepen S, Basir MB, Grines CL, Diercks DB, Hall S, Kapur NK, Kent W, Rao SV, Samsky MD, Thiele H, Truesdell AG, Henry TD. SCAI SHOCK Stage Classification Expert Consensus Update: A Review and Incorporation of Validation Studies: This statement was endorsed by the American College of Cardiology (ACC), American College of Emergency Physicians (ACEP), American Heart Association (AHA), European Society of Cardiology (ESC) Association for Acute Cardiovascular Care (ACVC), International Society for Heart and Lung Transplantation (ISHLT), Society of Critical Care Medicine (SCCM), and Society of Thoracic Surgeons (STS) in December 2021. J Am Coll Cardiol. 2022 Mar 8;79(9):933-946. doi: 10.1016/j.jacc.2022.01.018. Epub 2022 Jan 31. No abstract available.

  PMID: 35115207 BACKGROUND

Related Links

• Hub \&amp; Spoke: Improving Cardiogenic Shock Outcomes at WellStar

MeSH Terms

Conditions

Shock, Cardiogenic

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Study Officials

• Alaide Chieffo, Prof

  IRCCS San Raffaele Hospital

  PRINCIPAL INVESTIGATOR

• Mario Iannaccone, MD

  San Giovanni Bosco Hospital, ASL Città di Torino

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alaide Chieffo, Prof

CONTACT

+390226437331; cecalaide@gmail.com

Mario Iannaccone, MD

CONTACT

+390112402851; mario.iannaccone@hotmail.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: June 26, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): November 3, 2026
• Study Completion (Estimated): December 3, 2026
• Last Updated: July 1, 2025

Record last verified: 2025-06

Locations

IT (16)