Superior Mesenteric Artery (SMA) syndrome is a rare condition that affects the digestive system by compressing the small intestine. Clinical trials investigating SMA syndrome explore a range of treatment evaluations, including surgical and nonsurgica...
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Found 17 Actively Recruiting clinical trials
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Researchers are studying patients with atrial fibrillation (AF), a common heart rhythm disorder, to better understand why some still experience ischemic strokes despite taking oral anticoagulant therapy (OAC). The study focuses on identifying clinical factors, cardiac serum biomarkers, and heart structure features that may be linked to breakthrough strokes and could improve risk prediction in high-risk AF patients. This observational study is conducted at a single center and aims to include at least 500 participants. Participants with AF who have had an acute ischemic stroke will be enrolled, including those with breakthrough strokes despite OAC use. The study does not involve any intervention but collects detailed clinical data, blood samples for cardiac biomarkers, and echocardiographic measurements of the left atrium and its appendage. Patients will undergo standardized follow-up visits every 12 months after enrollment, with a minimum follow-up period of 12 months. During the study, researchers will assess recurrent ischemic stroke or systemic embolism as the primary outcome, measured at the first follow-up around 12 months and annually thereafter. Secondary outcomes include all-cause death, major adverse cardiac events, episodes of symptomatic AF, and functional outcomes such as disability and quality of life. The study aims to enhance understanding of stroke risk factors in AF patients to guide future treatment decisions and improve risk stratification.
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Healthy Volunteer
Researchers are studying two proteins, cleaved caspase-3 and dystrophin, in the blood to see if their levels rise during acute myocardial infarction (heart attack) and if they are higher in those who develop heart failure afterward. These proteins are linked to heart muscle damage and may be detected using laboratory methods. The study aims to understand whether these markers can help identify people at risk of heart failure after a heart attack. The study observes men and women aged 18 and older who have had an acute myocardial infarction, with or without heart failure. A control group of men aged 60 and above without a history of heart attack or heart disease is also included. Researchers measure blood levels of the two proteins using laboratory tests. Heart failure diagnosis may involve imaging tests to assess heart function. The study does not involve interventions but monitors natural changes in these markers. Participants will be followed for up to three years to track hospitalizations for heart attack, stroke, or death. Researchers collect blood samples and clinical data to compare protein levels between those who develop heart failure and those who do not. The study includes monitoring heart function by imaging and clinical assessments. Participants’ health outcomes over time help determine the relationship between the proteins and heart disease progression.
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Researchers are evaluating the effectiveness of endoscopic Coeliac Artery Release (eCAR) compared to a sham operation in patients suspected of Median Arcuate Ligament Syndrome (MALS). MALS involves significant external compression of the coeliac artery causing chronic disabling abdominal pain, weight loss, and related symptoms. The study aims to resolve ongoing debates about this condition by providing evidence on whether surgical release improves symptoms and quality of life. Participants are randomly assigned to either the eCAR procedure or a sham operation, both involving similar incisions to maintain blinding. The eCAR involves cleaving the median arcuate ligament via an endoscopic retroperitoneal approach using a specific four-trocar technique. The sham group undergoes incisions and anesthesia for a similar duration without ligament release. Procedures are performed by experienced surgeons, and patients and observers remain blinded to treatment allocation. During the study, participants are followed up for two years with assessments of abdominal pain, symptom relief using VAS and PGI-I scales, quality of life, productivity loss, healthcare use, and anatomical success measured by imaging. Safety is monitored through complication classification and additional treatments recorded. The primary outcome is symptom reduction measured six months after randomization. This comprehensive monitoring helps determine the value of eCAR for managing MALS and its impact on patient wellbeing and healthcare costs.
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Researchers are investigating intestinal ischemia and related vascular diseases through a specialized intensive care unit called SURVI, established within the Paris-Nord Val de Seine University Hospital Group with support from AP-HP. This unit focuses on managing acute and chronic mesenteric ischemias and intestinal vascular diseases without ischemia. These conditions involve serious blood flow problems in the digestive system, and without treatment, acute mesenteric ischemia can be fatal. The study aims to better understand the prevalence, risks, and outcomes of these rare and varied vascular diseases over time. This research is an observational study that follows a group of patients with intestinal vascular ischemia (IMVI) and other intestinal vascular diseases without ischemia (IIVD). Patients included have conditions such as acute or chronic mesenteric ischemia or other arterial or venous gastrointestinal vascular diseases. The study collects data to track the natural history of these diseases, as current knowledge about their progression and outcomes is limited. No experimental treatments are administered; instead, patient health and disease progression are monitored over the years. Participants in this study will be followed longitudinally with assessments focused on mortality rates at one and five years, disease prevalence, risk factors for complications like intestinal resection, and rates of vascular restenosis or ischemic events. The study also examines the impact of these diseases on outcomes such as short intestinal syndrome and dependence on parenteral nutrition after surgery. Data collection includes clinical evaluations and medical records over an extended period, allowing researchers to better understand disease patterns and factors affecting patient survival and quality of life.
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Researchers are evaluating treatments for chronic mesenteric ischemia (CMI), a condition caused by narrowing of arteries supplying blood to the intestines. This prospective, randomized controlled trial compares two types of stents: bare metal stents (BMS) and covered stents (CS). The study aims to assess outcomes such as stent openness one year after placement, complications, reoperation rates, quality of life, and reasons for death in patients with symptomatic CMI. Participants will be randomly assigned to receive either a BeSmooth bare metal stent or a BeGraft covered stent, both made by Bentley Innomed GmbH. The stents have identical metal structures, differing only in the graft covering. Blood samples will also be collected to study disease markers and their effects on treatment outcomes. The study follows patients for primary outcomes at 12 months and secondary outcomes including survival and quality of life for up to 5 years. During the study, participants will undergo evaluations including imaging to confirm artery narrowing and procedure-related monitoring. Researchers will track stent patency, complications related to the procedures, and quality of life using SF-36 questionnaires. Risks include less than 5% chance of procedure-related complications such as bleeding, thrombosis, impaired kidney function from contrast, and rare serious events. The total participation duration includes follow-up visits for up to five years to monitor long-term outcomes.
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Researchers are examining how blood flow in the superior mesenteric artery (SMA) changes after feeding in critically ill patients in the intensive care unit (ICU). The study seeks to understand the connection between these blood flow changes and the risk of Acute Gastrointestinal Injury (AGI), aiming to develop a model that predicts AGI risk based on SMA blood flow reactivity. This research focuses on improving enteral nutrition safety and patient outcomes by tailoring feeding strategies using intestinal blood flow information. The study uses enteral nutrition with intact protein formulas delivered through a nasogastric tube, starting at a rate of 20 ml per hour for 24 hours. Feeding adjustments are made based on real-time monitoring of SMA blood flow using bedside Doppler ultrasound. This observational approach allows researchers to closely observe how intestinal blood flow responds to feeding and its relation to gastrointestinal function. Participants will be monitored from enrollment through at least three days of treatment, with assessments focusing on feeding intolerance and gastrointestinal status. Researchers will use ultrasound to track SMA blood flow changes and evaluate hemodynamic indicators. The study aims to identify patterns in blood flow that predict gastrointestinal injury, enhancing personalized nutrition plans. Overall participation will include these monitoring and feeding evaluations during the hospital stay.
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Researchers are investigating whether using an endoscopically placed lumen apposing metal stent can be an effective alternative to surgery for patients who need reversal of their Roux-en-Y gastric bypass. This open-label pilot study focuses on patients with clear indications for bypass reversal due to complications such as hypoglycemia, gastric outlet obstruction, steatohepatitis, or difficulty with parenteral support. The study involves an endoscopic ultrasound-guided procedure using the Hot AXIOS™ Stent and Electrocautery-Enhanced Delivery System to create a gastro-gastrostomy. The excluded stomach is identified and punctured under fluoroscopic control, and a 20mm diameter lumen-apposing metal stent is placed to connect the stomach sections. This device-based intervention is performed following manufacturer instructions and fluoroscopy is used to confirm placement. Participants will be monitored for clinical success at 6 months, with additional assessments over 12 months including technical success, procedure duration, complication rates, and need for reintervention. The study tracks these outcomes to evaluate the procedure's effectiveness and safety. Overall involvement includes the treatment procedure and follow-up visits for outcome measurement and monitoring over at least one year.
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Researchers are studying patients who experience chest pain or discomfort and breathlessness but do not have blockages in their heart arteries, a condition called angina or ischemia with non-obstructive coronary arteries (ANOCA/INOCA). This registry aims to understand how common these conditions are, their causes, and the best ways to diagnose them, as well as to track long-term health outcomes in this group. Participants will undergo detailed heart evaluations as part of their standard care, including coronary angiography, intravascular ultrasound, and various tests of coronary artery function such as endothelial and microvascular assessments. Data from these procedures, along with tests for myocardial bridging and other coronary abnormalities, will be collected and entered into a research database. During the study, participants may be contacted periodically by phone or email for surveys and updates on their health status at 6 months, 1 year, 3 years, 5 years, 10 years, and every 5 years thereafter. Researchers will monitor outcomes including major cardiovascular events and changes in angina symptoms over up to 15 years. This long-term follow-up will help identify specific types of ANOCA and factors linked to cardiovascular risks.
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Researchers are evaluating the performance and safety of the GT Metabolic Magnet System, a device designed to create side-to-side compression anastomosis in the stomach and/or small bowel. The study focuses on adults with gastrointestinal disorders such as partial small bowel obstruction, superior mesenteric artery syndrome (SMAS), or gastric outlet obstruction (GOO), conditions that involve physical or mechanical blockage of the gastrointestinal tract. These similarities make the Magnet System a potential surgical tool to address these issues as part of clinical treatment. Participants will receive treatment using the GT Metabolic Magnet System, which aims to form a magnetic compression anastomosis for intestinal diversion. The procedure involves placing magnets to create the anastomosis without the immediate need for lumen patency. The study includes monitoring the placement of the magnet on the first day, observing natural magnet passage, and assessing anastomosis patency over a 90-day period. This interventional study does not use blinding or randomization and focuses on the single experimental device. During the study, participants will be closely monitored through evaluations measuring magnet placement and passage, as well as the condition of the anastomosis up to 90 days post-procedure. Researchers will assess safety and device performance. Participants must follow study requirements, including surgical clearance and contraception use if applicable. The total duration includes the initial procedure and follow-up assessments to ensure proper device function and participant safety.
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Healthy Volunteer
Researchers are investigating plasma Alpha glutathione S transferase (Alpha GST) levels in patients with chronic mesenteric ischemia (CMI) and median arcuate ligament syndrome (MALS), conditions that cause abdominal pain and weight loss. The study compares these levels to those in patients with Morbus Crohn, gallstone disease, and healthy individuals, aiming to find better biomarkers for intestinal ischemia and assess changes in quality of life. This observational study includes patients diagnosed by imaging and healthy controls, exploring Alpha GST alongside other potential markers like intestinal fatty acid binding protein, citrulline, and ischemia-modified albumin. Participants receive different treatments based on their condition: patients with MALS undergo laparoscopic surgery to release the celiac artery, while those with CMI receive open bypass surgery or endovascular treatment with PTA and stenting. Control groups include patients scheduled for gallbladder removal or with Crohn's disease, as well as healthy blood donors. Blood samples are collected at inclusion and three months later, with imaging used to confirm diagnoses and exclude conditions in controls. Participants complete questionnaires about symptoms and quality of life, including the EuroQol 5D (EQ-5D), at various points up to 10 years after treatment. Follow-up visits include clinical assessments and duplex ultrasound to monitor outcomes. The study also collects data on treatment complications and costs to analyze quality-adjusted life years and cost-utility. The main outcome measured is plasma Alpha GST levels at three months, with long-term tracking of clinical outcomes and quality of life up to 10 years.
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