CardioLogical Interventions and Acute strOke Treatment sTudy

NCT07314476 | Not Yet Recruiting DMC

• 1 other identifier: 1.0 - 08/02/2025
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to investigate characteristics and prognosis of ischemic stroke cases following cardiological interventions, focusing on the effectiveness and safety of acute ischemic stroke treatments.

Conditions

Acute Ischemic Stroke AIS; Stroke Treatment; PCI Patients; Aortic Valve Replacement; Transcatheter Aortic Valve Replacement (TAVR); Mitral Valve Repair; Mitral Valve Replacement; Left Atrial Appendage Closure; Transcatheter Pulmonary Valve Replacement (TPVR)

Keywords

acute ischemic stroke; acute ischemic stroke treatments; cardiological intervention

Outcome Measures

Primary Outcomes (5)

• CLOT-R primary outcome - Stroke severity

  Stroke severity assessed via the National Institutes of Health Stroke Scale (NIHSS). Scores on the NIHSS range from 0 to 42, with higher scores indicating more severe neurological deficits.

  from enrollment to 180 days follow-up

• CLOT-R primary outcome - Radiology

  Number of participants with large vessel occlusion demonstrated on neuroimaging.

  from enrollment to 180-day follow-up

• CLOT-R primary outcome - Cardiological procedure

  Number of participants who underwent cardiological procedures during which ischemic stroke occurred.

  from enrollment to 180-day follow-up

• CLOT-P primary outcome - Efficacy

  Number of participants presenting with Modified Rankin Scale (mRS) score ≤2 after revascularization. Scores on the mRS range from 0 to 6, with 0 indicating no symptoms and 6 indicating death. A score of 2 or less indicates functional indipendence.

  90-day follow-up

• CLOT-P primary outcome - safety

  Number of participants with symptomatic intracranial hemorrhage after revascularization.

  90-day follow-up

Secondary Outcomes (4)

• CLOT-R secondary outcome - Efficacy

  90-day follow-up

• CLOT-R secondary outcome - Safety

  90-day follow-up

• CLOT-R secondary outcome: Serious Adverse Event (SAE)

  90-day follow-up

• CLOT-P secondary outcome: Serious Adverse Event (SAE)

  90-day and 180-day follow-up

Study Arms (1)

Patients with ischemic stroke occuring within 28 days after cardiological interventional procedures

Cardiological interventions includes: Percutaneuous Coronary Intervention - PCI, Transcatheter Aortic Valve Replacement - TAVR, Baloon Aortic Valvuloplasy - BAV, Percutaneous Mitral Valve Repair or Replacement, Patent Formaen Ovale - PFO - or Atrial Septal Defects - ASD - Closure, Left Atrial Appendage Closure, Transcatheter Pulmonary Valve Replacement, Percutaneous Closure of Paravalvular Leaks

Eligibility Criteria

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

Study Population

Acute ischemic stroke in adult patient (\>18 years old) after cardiological intervention, male and female.

You may qualify if:

• acute ischemic stroke in adult patient (18 years of age or older) as diagnosed according to the World Health Organization (WHO) criteria;
• stroke with evidence of CT/MRI DWI/FLAIR acute lesion in the first neuroimaging or in the follow-up at 24-48 h;
• interventional cardiological procedures performed within 28 days since the stroke onset (Percutaneuous Coronary Intervention - PCI, Transcatheter Aortic Valve Replacement - TAVR, Baloon Aortic Valvuloplasy - BAV, Percutaneous Mitral Valve Repair or Replacement, Patent Formaen Ovale - PFO - or Atrial Septal Defects - ASD - Closure, Left Atrial Appendage Closure, Transcatheter Pulmonary Valve Replacement, Percutaneous Closure of Paravalvular Leaks);
• written informed consent provided by the patient himself or by proxy (for unconscious patients, cognitively impaired, or aphasic).

You may not qualify if:

• Stroke-like symptoms due primarily to another non-ischemic/hemorrhagic acute neurological condition or stroke mimics (e.g. severe hypo- or hyperglycemia, migraine with aura, functional disorders, etc);
• Spontaneous and post traumatic hemorrhagic stroke or spontaneous/post-traumatic subarachnoid hemorrhage or subdural hematoma;
• AciuImpossibility to achieve written informed consent

Sponsors & Collaborators

• University of L'Aquila: lead
• Rete delle NeuroCardiologie: collaborator

Study Sites (1)

Department of Biotechnological and Applied Clinical Sciences

L’Aquila, L'Aquila, 67100, Italy

Location

Related Publications (4)

• D'Anna L, Demir O, Banerjee S, Malik I. Intravenous Thrombolysis and Mechanical Thrombectomy in Patients with Stroke after TAVI: A Report of Two Cases. J Stroke Cerebrovasc Dis. 2019 Oct;28(10):104277. doi: 10.1016/j.jstrokecerebrovasdis.2019.06.035. Epub 2019 Jul 18.

  PMID: 31327683 BACKGROUND

• Powers WJ, Rabinstein AA, Ackerson T, Adeoye OM, Bambakidis NC, Becker K, Biller J, Brown M, Demaerschalk BM, Hoh B, Jauch EC, Kidwell CS, Leslie-Mazwi TM, Ovbiagele B, Scott PA, Sheth KN, Southerland AM, Summers DV, Tirschwell DL. Guidelines for the Early Management of Patients With Acute Ischemic Stroke: 2019 Update to the 2018 Guidelines for the Early Management of Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2019 Dec;50(12):e344-e418. doi: 10.1161/STR.0000000000000211. Epub 2019 Oct 30.

  PMID: 31662037 BACKGROUND

• Shah R, Wilkins E, Nichols M, Kelly P, El-Sadi F, Wright FL, Townsend N. Epidemiology report: trends in sex-specific cerebrovascular disease mortality in Europe based on WHO mortality data. Eur Heart J. 2019 Mar 1;40(9):755-764. doi: 10.1093/eurheartj/ehy378.

  PMID: 30124820 BACKGROUND

• D'Anna L, Abu-Rumeileh S, Merlino G, Ornello R, Foschi M, Diana F, Barba L, Mastrangelo V, Romoli M, Lobotesis K, Bax F, Kuris F, Valente M, Otto M, Korompoki E, Sacco S, Gigli GL, Nguyen TN, Banerjee S. Safety and Outcomes of Mechanical Thrombectomy in Acute Ischemic Stroke Attributable to Cardiological Diseases: A Scoping Review. J Am Heart Assoc. 2024 Sep 3;13(17):e034783. doi: 10.1161/JAHA.124.034783. Epub 2024 Jun 14.

  PMID: 38874062 BACKGROUND

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Matteo Foschi, MD

CONTACT

+390863499322; matteo.foschi@graduate.univaq.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 180 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Neurology

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: January 2, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: January 7, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)