The Stroke Aetiology and VascuLar Disease in Stroke and TIA Study - A Clinical Study Analysing the Effects on Cardiovascular Health and Disease With an Extended Investigation Into Conditions Causative of Stroke and Concomitant Cardiovascular Disease in Patients Admitted for Acute Stroke or TIA

NCT07491744 | Enrolling By Invitation

• 1 other identifier: 2022-02359-01
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

Annually, about 4000 Swedes suffer a recurrent stroke, and for many, their lives change dramatically. To prevent recurring strokes, knowledge about the individual's risk of recurrence is needed to tailor an effective preventive medical treatment. The purpose of the SALSA study is to investigate whether an expanded risk assessment and subsequent treatment can reduce the recurrence of stroke in study patients. Stroke, i.e., infarction/bleeding in the brain, has several different causes that individually or together constitute the risk of recurrence. Furthermore, stroke patients often have concomitant vascular diseases in other vascular beds, which further increases the risk. Every fourth patient with acute stroke or transient ischemic attack (TIA) admitted to any of the stroke wards at Danderyd Hospital, Stockholm, Sweden, is consecutively invited to participate in the SALSA study. Those who accept the study invitation, receive an expanded investigation of the most common causes of cerebral infarction (atherosclerosis, atrial fibrillation, narrowing of the brain\'s small vessels) or brain haemorrhage (presence of the protein amyloid in the vessels, high blood pressure). Due to the high risk of stroke patients having a vascular disease, such as atherosclerosis, the presence of arterial stiffness in the aorta, 24-hour blood pressure, and blood circulation in the legs are examined at the follow-up visit. If vascular disease is detected, expanded preventive treatment is provided. Neither a general investigation of the most common stroke aetiologies in addition to the one assessed to have caused the current stroke nor examinations of other vascular beds are recommended in national stroke guidelines. In addition to the extended risk assessment, the patient will get a written treatment program tailored after the individual patient's risk profile. The compliance to this treatment program will be assessed during a return visit one year after the hospital stay. After this visit, the active participation in the study is completed for the study participant. During the remainder of the follow-up, the study participant will be followed in national medical registers. The remaining 3/4 of patients at Danderyd Hospital constitute the comparison group, who are investigated and treated according to routine and hence do not undergo the additional vascular examinations. Stroke recurrence and other cardiovascular events occurring within the next 5-10 years will be compared between study patients and the comparison group via the national stroke registry containing all stroke and TIA patients at Danderyd Hospital.

Conditions

Stroke, Acute Ischemic; Intracerebral Hemorrhage; TIA; Hypertension; Arterial Stiffness; Periferal Arterial Occlusive Disease, PAOD; Cardiovascular Diseases

Keywords

epidemiology; cardiovascular risk; stroke; cardiovascular disease; cardiovascular prevention

Outcome Measures

Primary Outcomes (1)

• Number of major adverse cardiovascular events (MACE)

  MACE = cardiovascular death, non-fatal myocardial infarction and stroke

  Total follow up of each study participant is up to 15 years.

Secondary Outcomes (3)

• Number of stroke

  Total follow up of each study participant is up to 15 years.

• Number of myocardial infarctions

  Total follow up of each study participant is up to 15 years.

• Number of cardiovascular deaths

  From inclusion in the study until December 31st 2036

Study Arms (2)

Study cohort

EXPERIMENTAL

Extended assessment of stroke aetiology and vascular disease with concomitant medical treatment according to guidelines of pathological findings. Written treatment protocol tailored from the individual combinations of stroke aetiology and vascular disease and including recommended targets for cardiovascular risk factors are provided for the patient.

Other: Extended assessment

Comparison cohort

NO INTERVENTION

Routine assessments, medical care and follow up.

Interventions

Extended assessment OTHER

Extended assessment of stroke aetiology and vascular disease with concomitant medical treatment according to guidelines of pathological findings. Written treatment protocol tailored from the individual combinations of stroke aetiology and vascular disease and including recommended targets for cardiovascular risk factors are provided for the patient.

Study cohort

Eligibility Criteria

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

You may qualify if:

• Admitted to the Danderyd Hospital Stroke Unit for acute stroke or TIA

You may not qualify if:

• The medical condition is assessed not to be a stroke or TIA
• The patient is not able to make an informed decision to enter the study

Sponsors & Collaborators

• Region Stockholm: lead

Study Sites (1)

Danderyd Hospital, Department of Neurology

Stockholm, Stockholm County, 182 88, Sweden

Location

MeSH Terms

Conditions

Ischemic Stroke; Cerebral Hemorrhage; Hypertension; Cardiovascular Diseases; Stroke

Interventions

Focused Assessment with Sonography for Trauma

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Intracranial Hemorrhages; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Point-of-Care Testing; Point-of-Care Systems; Patient Care Management; Health Services Administration

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Parallell arms of study cohort and comparison cohort. Intervention in the study cohort: expanded etiological assessment and mapping of other macrovascular disease with concomittant medical treatment of pathological findings according to current guidelines.

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: March 24, 2026
• Study Start: January 25, 2023
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2036
• Last Updated: March 24, 2026

Record last verified: 2026-03

Locations

SE (1)