Clinical Research Directory

Presence of Dural Pulsation in Patients Diagnosed With Lumbar Spinal Stenosis

Lumbar spinal stenosis is defined as the narrowing of the spinal canal resulting from degenerative changes in the spinal joints, intervertebral discs, and the ligamentum flavum. Pressure fluctuations within the cerebral and spinal vascular systems lead to the formation of pulsations. The periodic occurrence of these pulsations in the dura mater is referred to as spinal dural pulsation.The vibratory movements of the dura mater have been interpreted as an indicator that the spinal cord is freely mobile within the subarachnoid space and not subjected to any external compression.This study aims to investigate whether the presence of dural pulsation is associated with clinical and radiological parameters in patients diagnosed with lumbar spinal stenosis

Tissue Characterization in STEMI Using Cardiac MRI: a Multicenter Registry

This multicenter registry includes patients with a first ST-segment elevation myocardial infarction (STEMI) who underwent cardiac magnetic resonance (CMR) imaging during the acute phase and follow-up. The registry is designed to identify clinical and CMR-derived predictors of adverse ventricular remodeling and major adverse cardiac events (MACE). CMR provides accurate and reproducible assessment of infarct size, left ventricular function, microvascular obstruction, and tissue characteristics, enabling detailed prognostic modeling.

Stress CMR With Vasodilators to Predict Long-Term Mortality

Objective We investigated the value of stress cardiac magnetic resonance (CMR) imaging with vasodilators for predicting long-term all-cause mortality in patients with known or suspected ischemic heart disease, using data from a large 15-year registry. Materials and Methods A total of 5,552 consecutive patients with known or suspected ischemic heart disease were included in a registry. They had been referred by their attending cardiologists for clinically indicated stress CMR with vasodilators between 2001 and 2016. All patients provided written informed consent prior to undergoing CMR. At the time of the CMR, clinical characteristics and both segmental and global CMR findings were collected. The presence and extent of stress-induced ischemia were recorded. The study hypothesis is that the presence of ischemia detected by stress CMR is associated with increased long-term all-cause mortality. The study will also explore whether CMR-related revascularization (triggered by ischemia on CMR and performed within the following three months) is associated with reduced long-term mortality. Clinical and CMR data were collected prospectively. Event follow-up will be conducted retrospectively for the purposes of this project through a review of patients' electronic medical records, following approval by the institutional ethics committee. Expected Results This study aims to provide conclusive evidence regarding the utility of stress CMR in predicting the most serious clinical outcome: all-cause mortality. It will also offer valuable insights into the potential therapeutic implications of CMR findings in terms of mortality reduction, depending on test results and subsequent management strategies. The large patient registry enables us to retrospectively address these key clinical questions, contributing to a more rational use of stress cardiac magnetic resonance and a more personalized approach to patient care.

Multicentre RCT of Awake Versus Asleep Tractography Based DBS for ET

Rationale: Deep brain stimulation (DBS) of the thalamus is an effective surgical treatment for patients with disabling essential tremor, despite optimal pharmacological treatment. To date, the standard DBS procedure is performed under local anesthesia which is very burdensome for patients. It is now possible to directly visualize the target (motor) area in the thalamus due to advances in modern imaging techniques. DBS surgery could be performed under general anesthesia (asleep). Objective: The primary objective of the study is to determine whether asleep thalamic DBS surgery provides an equal tremor reduction compared to awake thalamic DBS surgery, measured by the clinically validated Essential Tremor Rating Assessment Scale after six months of DBS. Secondary outcomes are: disease related daily functioning, adverse effects, operation time, quality of life, patient satisfaction with treatment outcome and patient evaluation of treatment burden. Study design: The study will be a multicentre prospective randomized open label blinded (PROBE) endpoint trial comparing thalamic DBS under general versus local anesthesia. Study population: A total of 110 patients with disabling essential tremor despite optimal pharmacological treatment will be randomized. Intervention (if applicable): Patients will be randomized for asleep DBS or awake DBS. According to the standard DBS procedure, two brain-electrodes are connected to an implanted neurostimulator, which is placed subcutaneously in the subclavicular area Main study parameter/endpoints: The primary outcome measure is the change in tremor score on the Essential Tremor Rating Assessment Scale after 6 months of thalamic DBS. The secondary outcome measures are the Amsterdam Linear Disability Score for functional health status, Quality of Life in Essential Tremor Questionnaire, patient satisfaction with the treatment, patient evaluation of treatment burden, operating time, hospitalization time, change of tremor medication, side effects and complications. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Awake DBS at present is very burdensome and by many patients and health care providers considered to be an overly invasive treatment for essential tremor. Through this trial, we aim to investigate whether asleep DBS in essential tremor can become the new treatment standard. This is expected to increase the accessibility for DBS and subsequently would allow more people with essential tremor to be helped, as well as in an earlier stage of their disease than currently; more patients will benefit for a longer time period from DBS. Asleep DBS will have a shorter procedure length. The proposed research project involves treatment options that are standard care in daily practice. The therapies will not be combined with other research products. Both treatments have a low risk of serious complications and a higher risk of minor side effects. Regular follow up will be used. Participation in this study constitutes moderate risk according to NFU criteria for human research.

Cardiac Magnetic Resonance Stress-perfusion Study in Patinets with Fontan Circulation

Univentricular heart (UVH) is a severe congenital heart disease. Accurate advanced non-invasive diagnostic methods is limited. Cardiovascular magnetic resonance (CMR) imaging has evolved as a particularly useful tool for the study of patients with adult congenital heart disease (ACHD) considering its ability to determine detailed anatomy and detect early cardiac dysfunction without the need for radiation exposure. Most of contemporary treatment recommendations are based on consensus opinions/documents and small studies from local, or national registries. Improved knowledge is needed in all these areas to facilitate clinical decisions regarding treatment, monitoring and follow-up. This study seeks to answer if early detection of deterioration in cardiac function, venous pressure and microvascular dysfunction can identify patients before the symptoms progress and thus help to initiate early treatment. The hypothesis is that quantitative myocardial stress-perfusion maps improves the pathophysiological insight in patients with UVH. The overall goal with this research proposal is to implement combined advanced CMR imaging for a comprehensive non-invasive mapping of functional cardiovascular behavior in patients with complex UVH disease. The outcome of this research may benefit this young adult patient population due to early detection of cardiac disease, less hospitalizations because of heart failure, and eventually decrease morbidity and mortality.