Biomarkers and Perfusion - Training-Induced Changes After Stroke "BAPTISe"

Active, not recruiting

Phase N/A Results N/A

Trial Description

The purpose of this observational study is to examine the effects of 4-weeks of physical fitness training in patients with subacute ischemic stroke on cerebral imaging and blood-derived biomarkers.

Detailed Description

This biomarker-driven study uses an observational design to examine a subgroup of patients in the randomized, controlled trial "Physical Fitness Training in Subacute Stroke" (PHYS-STROKE). In PHYS-STROKE, 215 patients with subacute stroke (hemorrhagic and ischemic) receive either 4-weeks of physical training (aerobic training, 5 times a week, for 50 minutes) or 4-weeks of relaxation sessions (5 times a week, for 50 minutes). A convenience sample of 100 of these patients with ischemic stroke will be included in BAPTISe and will receive magnetic resonance imaging (MRI) scans and blood tests before and after the PHYS-STROKE intervention. Imaging scans will address parameters of cerebral perfusion and vessel size imaging. Blood tests will determine several parameters such as immunity, inflammation (including neopterin, MMP-9), metabolism (including ApoCIII, oxidized LDL, HOMA-index, uric acid, CK-MB, cystatin c, and leptin), cytokines (osteopontin, adiponectin), and endothelial function (SDF1-alpha, ADMA, sICAM, sVCAM, E-selectin, P-selectin). Additionally, we will assess the association between functional outcomes (co-primary outcome measures of PHYS-STROKE) and biomarkers including imaging results.

Conditions

Trial Design

  • Observation: Case Control
  • Perspective: Prospective
  • Sampling: Non-Probability Sample

Trial Population

Patients recruited for this study are collected at the rehabilitation hospital and are participating in the PHYS-STROKE trial.

Outcomes

Type Measure Time Frame Safety Issue
Primary Cerebral imaging and Blood-derived biomarkers baseline and 4-weeks No
Secondary next cerebrovascular event 6 months Yes
Secondary functional outcome directly after the end of intervention and 3 months post stroke No
Primary Cerebral perfusion baseline and 4-weeks No
Primary Blood-derived biomarkers baseline and 4-weeks No

Biospecimen Retention:Samples With DNA - Patients will receive blood draws (whole blood) for blood biomarker analyses.

Sponsors