MULTINEUR: Platelet Function and Neurological Events

• Sponsor: Scientific Institute San Raffaele (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05572320
• Collaborator: (none)
• Enrollment: 386
• Location: 1
• Anticipated Duration (Months): 35.4
• Patients Per Site Per Month: 10.9

Study Details

Study Description

Brief Summary

Several studies have shown an association between platelet function and stroke in patients undergoing carotid thromboendarterectomy (TEA).

The present study will assess the correlation between platelet function evaluated by the impedance aggregometry and neurological events in patients undergoing carotid TEA.

Condition or Disease	Intervention/Treatment	Phase
Stroke, Acute; Carotid Artery Diseases	Diagnostic Test: Platelet Aggregometry Testing

Detailed Description

Carotid thrombendarterectomy (TEA) is effective in preventing strokes which are a major cause of mortality and morbidity. Nevertheless, almost 10% of patients undergoing TEA develop a transient and/or permanent neurological injury. There is a growing body of evidence that platelet function is associated with perioperative neurological events in this setting, although the vast majority of patients undergoing carotid TEA are already on antiplatelet agents. The aim of the present study will be to assess the correlation between the platelet function evaluated by the impedance aggregometry (Multiplate ® Analyzer, Roche, Basel, Switzerland) and neurological events in patients undergoing carotid TEA.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 386 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Platelet Function and Neurological Events Following Carotid Thromboendarterectomy
• Actual Study Start Date: Oct 10, 2022
• Anticipated Primary Completion Date: Sep 20, 2024
• Anticipated Study Completion Date: Sep 20, 2025

Outcome Measures

Primary Outcome Measures

1. Platelet function and neurological events [immediately before the surgery]

   The platelet function will be evaluated by Multiple Electrode Aggregometry (Multiplate). It will be asses the correlation between thrombin receptor activator peptide 6 (TRAP test), adenosine-5'-diphosphate (ADP test) and arachidonic acid (ASPI test) expressed in arbitrary units area under the curve and neurological events in patients undergoing carotid thrombendarterectomy

2. TRAP, ADP and ASPI thresholds to predict neurological events [immediately before the surgery]

   It will be find the best cut-off for TRAP, ADP and, ASPI in predicting neurological events

Secondary Outcome Measures

1. Occurence of thromboembolic neurological events [within 1 month of patients' enrolled or before the hospital discharge]

2. Occurrence of any complications [within 1 month of patients' enrolled or before the hospital discharge]

   Occurrence of surgical and medical complications

3. 6 months and 1 year mortality [6 months and 1 year]

   Mortality at 6 months and 1 years after carotid surgery

4. 6 months and 1 year neurological events [6 months and 1 year]

   Occurrence of neurological events after 6 months and 1 year after the procedure

Other Outcome Measures

1. Assesment of the health state at 6 months and 1 year after surgery [6 months and 1 year]

   The health state will be evaluated by EuroQol 5-dimensions 3 level test at 6 months and 1 year

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age > 18 years

• Carotid Artery Diseases undergoing carotid thrombendarterectomy

• Signed consent

Exclusion Criteria:

• Atrial fibrillation

• New oral anticoagulant

• Oral Vitamin k inhibitors

• Platelet count <80000 per microliter

• Ongoing ischemic stroke

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Scientific Institute San Raffaele	Milan		Italy	20132

Sponsors and Collaborators

• Scientific Institute San Raffaele

Investigators

• Principal Investigator: Fabrizio Monaco, MD, San Raffaele Scientific Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

• Ball STE, Taylor R, McCollum CN. Resistance to Antiplatelet Therapy Is Associated With Symptoms of Cerebral Ischemia in Carotid Artery Disease. Vasc Endovascular Surg. 2020 Nov;54(8):712-717. doi: 10.1177/1538574420947235. Epub 2020 Aug 28.
• Reavey-Cantwell JF, Fox WC, Reichwage BD, Fautheree GL, Velat GJ, Whiting JH, Chi YY, Hoh BL. Factors associated with aspirin resistance in patients premedicated with aspirin and clopidogrel for endovascular neurosurgery. Neurosurgery. 2009 May;64(5):890-5; discussion 895-6. doi: 10.1227/01.NEU.0000341904.39691.2F.
• Sacco S, Stracci F, Cerone D, Ricci S, Carolei A. Epidemiology of stroke in Italy. Int J Stroke. 2011 Jun;6(3):219-27. doi: 10.1111/j.1747-4949.2011.00594.x.

• Responsible Party: Fabrizio Monaco, Head of Cardiothoracic and Vascular Anesthesia, Scientific Institute San Raffaele
• ClinicalTrials.gov Identifier: NCT05572320
• Other Study ID Numbers: CE:83/INT/2022
• First Posted: Oct 7, 2022
• Last Update Posted: Oct 12, 2022
• Last Verified: Oct 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Fabrizio Monaco, Head of Cardiothoracic and Vascular Anesthesia, Scientific Institute San Raffaele: Carotid thromboendarterectomy; Thromboembolic Stroke; Platelet function; Aggregometry; Vascular surgery; mortality; neurological events
• Additional relevant MeSH terms: Stroke; Carotid Artery Diseases

Study Results

No Results Posted as of Oct 12, 2022