Raynaud's Phenomenon

Raynaud's Phenomenon (RP) is a common condition where small blood vessels in the skin have spasms that reduce blood flow. It affects about 5% of the population and can cause symptoms ranging from mild pain and color changes to severe pain, impaired hand function, and tissue damage. This research aims to assess the effects of Botulinum toxin (BT) in patients with RP that does not respond to standard treatments, using both objective and patient-reported measures. The study is a double-blinded, randomized, placebo-controlled trial conducted at a single site. Participants will be randomly assigned to receive injections in their finger bases of either a placebo, 10 units of BT per digit, or 20 units of BT per digit. Before injection, patients rest in a temperature-controlled room to normalize finger temperature. The injections are administered by hand surgeons using a standardized technique to ensure safety and accurate placement. Participants will be evaluated over 24 weeks following injection. Measurements will include finger temperature and tissue oxygen levels at baseline, 4, 12, and 24 weeks. Patient-reported outcomes will assess pain, hand function, and Raynaud's symptoms through questionnaires conducted in person and by phone. The study aims to establish a standard BT injection method and dosage, monitoring changes in symptoms and tissue health throughout the study period.

Researchers are evaluating the safety and effectiveness of intramuscular administration of Stempeucel (adult human bone marrow-derived, cultured, pooled, allogeneic mesenchymal stromal cells) in Malaysian patients with critical limb ischemia (CLI) caused by Buerger's disease. This observational, practice-based feasibility study aims to see if Stempeucel can reduce CLI symptoms, improve ulcer healing, and enhance functional outcomes while monitoring for any serious adverse events. The treatment involves a single arm where Stempeucel cells are supplied in cryo-bags containing 150 or 200 million cells suspended in a liquid mixture. The dose is based on body weight, with injections administered intramuscularly into various points on the muscles, including additional injections around the ulcer. The study is planned to last approximately 18 months, with treatment and follow-up occurring during this period. Participants will be assessed before treatment and monitored over one year after administration for safety and effectiveness. Evaluations include measurement of ischemic rest pain, ulcer size, ankle brachial pressure index, walking distance, amputation-free survival, and angiogenesis at multiple time points up to 360 days. Safety assessments involve tracking adverse events, laboratory tests, vital signs, physical exams, ECGs, and chest condition, with data recorded electronically for analysis.

Researchers are investigating the effects of norepinephrine, a common medication used to treat septic shock, on blood flow and tissue perfusion in adults. Septic shock can cause a mismatch between overall blood circulation and the actual delivery of blood to cells, and this study aims to better understand how norepinephrine influences these factors. This observational study will provide important insights to help tailor treatment based on individual patient needs. Participants in this study are adult patients with septic shock who are sedated and mechanically ventilated in intensive care units. The study involves carefully monitored adjustments to norepinephrine dosage, including stepwise reductions and increases, alongside fluid challenges to assess how these changes affect stroke volume and blood pressure. Extended monitoring equipment will be used to collect clinical and biochemical data, and tests like the passive leg raise will help predict fluid responsiveness. During the study, researchers will continuously measure stroke volume and cardiac output using various methods, including arterial waveform analysis and Doppler ultrasound. They will evaluate how changes in norepinephrine and fluid administration impact heart function and microcirculation over approximately one year. Safety checks and detailed monitoring are integral parts of the process, ensuring participant well-being while gathering data to improve management of septic shock.

Researchers are investigating the use of a full-body multi-modal imaging technology to help with screening, monitoring, and diagnosing various skin and circulatory conditions in primary care. This study focuses on assessing the accuracy of body measurements and the technology's ability to detect skin cancer, peripheral arterial disease, Raynaud's phenomenon, and other dermatological conditions. The imaging system combines high-resolution 2D and 3D color photos with thermal images to capture detailed information about skin lesions and microcirculation. The imaging technology uses camera systems that include 2D color cameras for capturing lesion appearance, 3D cameras for geometric alignment and measurements, and thermal cameras for detecting temperature changes linked to skin and vascular diseases. Participants will have full-body images taken from the front and back during their primary care visit. Some participants may also have manual body measurements taken as part of routine care. Those interested may have repeated image and measurement sessions yearly. Participants will fill out a questionnaire about their medical history related to the studied conditions during the visit. Researchers will evaluate the sensitivity of the imaging for detecting lesions needing removal, dermatological conditions, and changes in lesions compared to visual inspection and traditional measurements. Thermal gradients will be analyzed for correlations with peripheral arterial disease and Raynaud's phenomenon. Follow-up assessments may occur at one year. The study offers a non-invasive way to collect detailed skin and body data with ongoing safety and diagnostic monitoring.

Researchers are investigating how resting blood pressure control differs between healthy males and females. The study focuses on the communication between the sympathetic nervous system, which controls the "fight or flight" response, and blood vessels that affect systemic blood pressure. It also examines how specific blood vessel receptors, called alpha and beta-adrenergic receptors, respond to sympathetic signals and whether their behavior differs by sex. Understanding these differences may help explain why blood pressure regulation varies between males and females. Participants will attend one approximately 3-hour study visit where they receive small doses of medications through a catheter in the arm to test blood vessel responses. These medications include blockers to alpha- and beta-adrenergic receptors, given alone or together, as well as agents that stimulate these receptors. During the visit, saline infusions control for volume effects. The study measures forearm blood flow and vascular resistance under different conditions with receptor blockades. During the visit, participants have blood samples taken to measure sex hormones and sympathetic neurotransmitters. Their muscle sympathetic nerve activity is recorded using fine needles in the leg. Blood pressure, heart rate, and forearm blood flow are monitored using ultrasound. The main outcomes measured include forearm blood flow, vascular resistance, vascular conductance, arterial blood pressure, muscle sympathetic nerve activity, and circulating hormone levels. The total study participation is a single visit, and safety is closely monitored throughout.

Researchers are evaluating whether injecting nicardipine directly into the cerebrospinal fluid improves outcomes for patients with cerebral vasospasm caused by aneurysmal subarachnoid hemorrhage. This multi-center, prospective, double-blinded, randomized controlled trial compares two methods of delivering nicardipine: through extraventricular drainage (EVD) or lumbar drainage (LD). The study aims to determine which approach leads to a better prognosis for affected patients. Participants in the treatment group receive intrathecal nicardipine injections via EVD or LD catheters. The process involves withdrawing 6 ml of cerebrospinal fluid, injecting 4 ml (4 mg) of nicardipine hydrochloride, followed by 2 ml of saline, then clamping the catheter for 2 hours. This dosing is done twice daily. The control group undergoes a simulated procedure without receiving the drug. The drainage tubes remain open as clinically needed between doses. During the study, participants are monitored for outcomes using multiple scales, including the Modified Rankin Scale at 90 and 365 days, Glasgow Outcome Score, MMSE, NIH Stroke Scale, and rates of complications like infections or hemorrhage. Safety is assessed through adverse event tracking. Follow-up visits occur up to one year after treatment. The entire study period spans from the start of treatment to long-term outcome evaluations.

Researchers are studying biomarkers collected from participants with cardiovascular and metabolic diseases to better understand these conditions. The study aims to create a lasting resource that supports collaboration between clinicians at Cleveland Clinic Main Campus and scientists at the Lerner Research Institute. This partnership will enhance research on vascular diseases using a shared biorepository tool. Participants will provide blood, urine, and/or stool samples, which will be collected prospectively and stored in a biobank. These samples, along with clinical data, will be used to explore various vascular and metabolic diseases such as peripheral artery disease, carotid disease, aneurysmal disease, chronic venous disease, thrombosis, lymphedema, lipedema, and other related conditions. The study also supports ongoing quality control and safety efforts in the Vascular Lab. During this observational study, participants will be asked to provide biological samples and clinical information over a period of up to 10 years. Researchers will use these samples to perform biochemical and genetic testing. The primary outcome is the collection and preservation of these samples for future research. The study supports interdepartmental collaboration to advance the understanding of vascular and metabolic diseases.