Body Cooling During Carotid Endarterectomy: No-profit, Open, Mono-centric, Feasibility Study

NCT02629653 | Completed

• 1 other identifier: CEAC-0613
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Aim of the study is to determine whether endovascular systemic cooling to a target temperature of 34-35°C initiated before, and maintained during Carotid EndoArterectomy (CEA), is feasible and safe

Conditions

Carotid Artery Diseases; Hypothermia; Stroke; Carotid Artery Plaque; Carotid Artery Stenosis; Cerebrovascular Accident

Keywords

carotid endarterectomy; stroke; hypothermia; endovascular cooling

Outcome Measures

Primary Outcomes (1)

• Adverse events

  Severe adverse events were defined as any life-threatening event including pneumonia (diagnosed on the basis of clinical signs or symptoms), myocardial infarction and parenchymal hemorrhage. Non-severe safety outcomes included incidence of bradycardia (\<40 beats per minute), cardiac arrhythmia, hypertension, hypotension and any coagulation disorders.

  Any adverse event at 1 month

Study Arms (1)

Single arm

OTHER

The endovascular cooling system will be Zoll IVTM. This system consists of a control module (either CoolGard 3000 or Thermogard XP), a CoolGard start-up kit, and an ICY catheter (either IC-3585 AE or IC-3585)

Device: endovascular cooling (Zoll system)

Interventions

endovascular cooling (Zoll system) DEVICE

The Zoll IVTM is an endovascular cooling system that consists of a control module (either CoolGard 3000 or Thermogard XP), a CoolGard start-up kit, and an ICY catheter (either IC-3585 AE or IC-3585).

Single arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject eligible for CEA, without progression of symptoms, with low (\<4) Anesthesia Risk Assessment
• Age ≥ 18 years;
• Written informed consent

You may not qualify if:

• Progression or instability of neurological status
• Conditions that may be exacerbated by hypothermia, such as haematological dyscrasias, oral anticoagulant treatment with INR ≥ 1.7, severe pulmonary disease, severe heart failure (defined as a New York Heart Association (NYHA) score of III or IV), history of myocardial infarction within the previous 3 months, angina pectoris in the previous 3 months, severe infection with a C-reactive protein \> 50 mg/dl, or a clinical diagnosis of sepsis;
• Blood oxygen saturation below 94%, allowing a maximum of 2 L/min oxygen delivered nasally to achieve this;
• Bradycardia (\<40 beats/min);
• Body weight \> 120 kg;
• Severe hepatic dysfunction, or severe renal dysfunction;
• Pregnancy. Women of childbearing potential are excluded unless a negative test for pregnancy has been obtained prior to randomisation;
• Other serious illness that may confound treatment assessment or increase the risks of cooling;
• Social or other conditions that according to the investigator's judgement might be a major problem for follow-up.

Sponsors & Collaborators

• S. Andrea Hospital: lead

Study Sites (1)

NESMOS Department St. Andrea Hospital

Rome, Rome, 00189, Italy

Location

Related Publications (9)

• Grotta JC. Clinical practice. Carotid stenosis. N Engl J Med. 2013 Sep 19;369(12):1143-50. doi: 10.1056/NEJMcp1214999. No abstract available.

  PMID: 24047063 RESULT

• Lee JH, Suh BY. Risk factor analysis of new brain lesions associated with carotid endarterectmy. Ann Surg Treat Res. 2014 Jan;86(1):39-44. doi: 10.4174/astr.2014.86.1.39. Epub 2014 Jan 1.

  PMID: 24761406 RESULT

• Endarterectomy for asymptomatic carotid artery stenosis. Executive Committee for the Asymptomatic Carotid Atherosclerosis Study. JAMA. 1995 May 10;273(18):1421-8.

  PMID: 7723155 RESULT

• Yenari MA, Han HS. Neuroprotective mechanisms of hypothermia in brain ischaemia. Nat Rev Neurosci. 2012 Feb 22;13(4):267-78. doi: 10.1038/nrn3174.

  PMID: 22353781 RESULT

• Erecinska M, Thoresen M, Silver IA. Effects of hypothermia on energy metabolism in Mammalian central nervous system. J Cereb Blood Flow Metab. 2003 May;23(5):513-30. doi: 10.1097/01.WCB.0000066287.21705.21.

  PMID: 12771566 RESULT

• Wu TC, Grotta JC. Hypothermia for acute ischaemic stroke. Lancet Neurol. 2013 Mar;12(3):275-84. doi: 10.1016/S1474-4422(13)70013-9.

  PMID: 23415567 RESULT

• van der Worp HB, Macleod MR, Kollmar R; European Stroke Research Network for Hypothermia (EuroHYP). Therapeutic hypothermia for acute ischemic stroke: ready to start large randomized trials? J Cereb Blood Flow Metab. 2010 Jun;30(6):1079-93. doi: 10.1038/jcbfm.2010.44. Epub 2010 Mar 31.

  PMID: 20354545 RESULT

• Kamme F, Campbell K, Wieloch T. Biphasic expression of the fos and jun families of transcription factors following transient forebrain ischaemia in the rat. Effect of hypothermia. Eur J Neurosci. 1995 Oct 1;7(10):2007-16. doi: 10.1111/j.1460-9568.1995.tb00623.x.

  PMID: 8542058 RESULT

• Candela S, Dito R, Casolla B, Silvestri E, Sette G, Filippi F, Taurino M, Brancadoro D, Orzi F. Hypothermia during Carotid Endarterectomy: A Safety Study. PLoS One. 2016 Apr 8;11(4):e0152658. doi: 10.1371/journal.pone.0152658. eCollection 2016.

  PMID: 27058874 DERIVED

MeSH Terms

Conditions

Carotid Artery Diseases; Hypothermia; Stroke; Carotid Stenosis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arterial Occlusive Diseases

Study Officials

• Francesco Orzi, Prof, MD

  NESMOS Department, University of Rome "La Sapienza"; St. Andrea Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof, MD

Study Record Dates

• First Submitted: December 10, 2015
• First Posted: December 14, 2015
• Study Start: December 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 14, 2015

Record last verified: 2015-12

Locations

IT (1)