Carotid Artery DiseasesNCT02629653
Body Cooling During Carotid Endarterectomy: No-profit, Open, Mono-centric, Feasibility Study
A study testing endovascular cooling (Zoll system) in people with Carotid Artery Diseases and Hypothermia, run by S. Andrea Hospital at 1 site in Italy.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Carotid Artery Diseases, Hypothermia, Stroke
- What is being tested?
- endovascular cooling (Zoll system)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2013to Dec 2015
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject eligible for CEA, without progression of symptoms, with low (<4) Anesthesia Risk Assessment
- Age ≥ 18 years;
- Written informed consent
Who cannot join
- Evidence from a CT or MRI scan or from other pre-inclusion investigations of an intracranial haemorrhage, a tumour, encephalitis, or any diagnosis of acute brain focal lesion;
- 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;
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the detailed description
The study is based on the hypothesis that performing CEA during hypothermia substantially reduces the risk due to a potential, temporary hypoperfusion, associated with the surgical procedure.
The rationale behind the study is based on the assumption that Carotid EndArterectomy (CEA), by removing local causes of downstream altered circulation, improves cerebral hemodynamics and provides an effective prevention of stroke and TIA. The intervention itself, however, causes immediate risk of stroke or death, and it is also an issue whether the temporary reduction of blood flow associated with clamping of the artery, during the surgical intervention, may trigger long-lasting brain tissue dysfunction.
Mild hypothermia (34-35 °C) is probably the most effective approach to protect the brain from ischemic insults. Most of the supportive data were obtained in animal models of ischemia. Several phase II trials have shown safety and feasibility of cooling subjects with stroke, in the hours following onset of symptoms. Early interventions show the highest benefit.
Eligible patients will initiate cooling 60-90 min before CEA with endovascular cooling (Zoll system) to the target 34-35°C (assessed by bladder thermometer). The Zoll IVTM system is an endovascular cooling system that consists of a control module (either CoolGard 3000 or Thermogard XP), a CoolGard start-up kit, an ICY catheter (either IC-3585 AE or IC-3585 CO or IC-3893 AE or IC-3893 CO), a catheter convenience kit for catheter insertion (CO models only), thermal probes and cables. All the devise component have CE mark. The Low temperature will be maintained during the CEA procedure, followed by gradual, passive, controlled rewarming (0.4 °C/h). Type of anaesthesia will be decided according to good clinical practice. The cooling procedure will be, therefore, carried out during the anaesthesia procedure required by the surgical intervention. There is a chance that the duration of the anaesthesia will be longer that required, but all the efforts will be undertaken to keep the anaesthesia time as short as if there were no cooling
Clinical and instrumental evaluations will be carried out before and post intervention. Each evaluation will consist of physical examination, neuropsychological evaluation (MoCA test), blood tests and brain MRI or TC.
Safety is evaluated on the basis of severe adverse event
- Conditions
- Carotid Artery Diseases, Hypothermia, Stroke, Carotid Artery Plaque, Carotid Artery Stenosis, Cerebrovascular Accident
- Being tested
- endovascular cooling (Zoll system)
- Keywords
- carotid endarterectomy, stroke, hypothermia, endovascular cooling
- Medical subject headings
- Carotid Artery Diseases, Hypothermia, Stroke, Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Device: endovascular cooling (Zoll system) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Any adverse event at 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2015 (estimated)
- Study startDec 2013
- Primary completionJun 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Carotid Artery DiseasesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- S. Andrea Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Orzi, S. Andrea Hospital
- Investigators
- Francesco Orzi, Prof, MD, Study chair, NESMOS Department, University of Rome "La Sapienza"; St. Andrea Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02629653
- Sponsor's protocol ID
- CEAC-0613
- Status last verified
- Dec 2015
- First submitted
- 10 Dec 2015
- Last updated
- 14 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Grotta JC. Clinical practice. Carotid stenosis. N Engl J Med. 2013 Sep 19;369(12):1143-50. doi: 10.1056/NEJMcp1214999. No abstract available.
PubMed 24047063Lee 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.
PubMed 24761406Endarterectomy for asymptomatic carotid artery stenosis. Executive Committee for the Asymptomatic Carotid Atherosclerosis Study. JAMA. 1995 May 10;273(18):1421-8.
PubMed 7723155Yenari MA, Han HS. Neuroprotective mechanisms of hypothermia in brain ischaemia. Nat Rev Neurosci. 2012 Feb 22;13(4):267-78. doi: 10.1038/nrn3174.
PubMed 22353781Erecinska 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.
PubMed 12771566Wu TC, Grotta JC. Hypothermia for acute ischaemic stroke. Lancet Neurol. 2013 Mar;12(3):275-84. doi: 10.1016/S1474-4422(13)70013-9.
PubMed 23415567van 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.
PubMed 20354545Kamme 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.
PubMed 8542058Candela 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.
PubMed 27058874
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body Cooling During Carotid Endarterectomy: No-profit, Open, Mono-centric, Feasibility Study
- ClinicalTrials.gov ID
- NCT02629653
- Acronym / sponsor ID
- CEAC-0613
- Conditions
- Carotid Artery Diseases, Hypothermia, Stroke, Carotid Artery Plaque, Carotid Artery Stenosis, Cerebrovascular Accident
- Keywords
- carotid endarterectomy, stroke, hypothermia, endovascular cooling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- S. Andrea HospitalUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 14 Dec 2015 (estimated)
- 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.
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
Detailed description
The study is based on the hypothesis that performing CEA during hypothermia substantially reduces the risk due to a potential, temporary hypoperfusion, associated with the surgical procedure.
The rationale behind the study is based on the assumption that Carotid EndArterectomy (CEA), by removing local causes of downstream altered circulation, improves cerebral hemodynamics and provides an effective prevention of stroke and TIA. The intervention itself, however, causes immediate risk of stroke or death, and it is also an issue whether the temporary reduction of blood flow associated with clamping of the artery, during the surgical intervention, may trigger long-lasting brain tissue dysfunction.
Mild hypothermia (34-35 °C) is probably the most effective approach to protect the brain from ischemic insults. Most of the supportive data were obtained in animal models of ischemia. Several phase II trials have shown safety and feasibility of cooling subjects with stroke, in the hours following onset of symptoms. Early interventions show the highest benefit.
Eligible patients will initiate cooling 60-90 min before CEA with endovascular cooling (Zoll system) to the target 34-35°C (assessed by bladder thermometer). The Zoll IVTM system is an endovascular cooling system that consists of a control module (either CoolGard 3000 or Thermogard XP), a CoolGard start-up kit, an ICY catheter (either IC-3585 AE or IC-3585 CO or IC-3893 AE or IC-3893 CO), a catheter convenience kit for catheter insertion (CO models only), thermal probes and cables. All the devise component have CE mark. The Low temperature will be maintained during the CEA procedure, followed by gradual, passive, controlled rewarming (0.4 °C/h). Type of anaesthesia will be decided according to good clinical practice. The cooling procedure will be, therefore, carried out during the anaesthesia procedure required by the surgical intervention. There is a chance that the duration of the anaesthesia will be longer that required, but all the efforts will be undertaken to keep the anaesthesia time as short as if there were no cooling
Clinical and instrumental evaluations will be carried out before and post intervention. Each evaluation will consist of physical examination, neuropsychological evaluation (MoCA test), blood tests and brain MRI or TC.
Safety is evaluated on the basis of severe adverse event
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Other | Device: endovascular cooling (Zoll system)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) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject eligible for CEA, without progression of symptoms, with low (<4) Anesthesia Risk Assessment
- Age ≥ 18 years;
- Written informed consent
Key exclusion criteria (10 listed)
- Evidence from a CT or MRI scan or from other pre-inclusion investigations of an intracranial haemorrhage, a tumour, encephalitis, or any diagnosis of acute brain focal lesion;
- 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);
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 |
|---|---|---|
| endovascular cooling (Zoll system)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). | Device | Single arm |
Primary outcome
Adverse events
Time frame: Any adverse event at 1 month
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.
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 14 Dec 2015.
- Results publication: PubMed 24047063Grotta JC. Clinical practice. Carotid stenosis. N Engl J Med. 2013 Sep 19;369(12):1143-50. doi: 10.1056/NEJMcp1214999. No abstract available.
- Results publication: PubMed 24761406Lee 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.
- Results publication: PubMed 7723155Endarterectomy for asymptomatic carotid artery stenosis. Executive Committee for the Asymptomatic Carotid Atherosclerosis Study. JAMA. 1995 May 10;273(18):1421-8.
- Results publication: PubMed 22353781Yenari MA, Han HS. Neuroprotective mechanisms of hypothermia in brain ischaemia. Nat Rev Neurosci. 2012 Feb 22;13(4):267-78. doi: 10.1038/nrn3174.
- Results publication: PubMed 12771566Erecinska 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.
- Results publication: PubMed 23415567Wu TC, Grotta JC. Hypothermia for acute ischaemic stroke. Lancet Neurol. 2013 Mar;12(3):275-84. doi: 10.1016/S1474-4422(13)70013-9.
- Results publication: PubMed 20354545van 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.
- Results publication: PubMed 8542058Kamme 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.
- Derived from this study: PubMed 27058874Candela 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.
- Individual participant dataSharing planned: Undecided
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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.
Francesco Orzi, Prof, MD study chair
NESMOS Department, University of Rome "La Sapienza"; St. Andrea Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endovascular cooling (Zoll system) in people with Carotid Artery Diseases and Hypothermia, run by S. Andrea Hospital at 1 site 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 3 inclusion and 10 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 14 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Adverse events (time frame: Any adverse event at 1 month). 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 NCT02629653, which also lists 9 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 14 Dec 2015.