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Mesenteric Ischemia clinical trials

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NCT ID: NCT05468580 Recruiting - Mesenteric Ischemia Clinical Trials

Coeliac Artery Release or Sham Operation

CARoSO
Start date: November 1, 2022
Phase: N/A
Study type: Interventional

In patients with Median Arcuate Ligament Syndrome (MALS), significant external compression of the coeliac artery (CA) by the median arcuate ligament (MAL) increasing mucosal ischemia (1,2) is assumed to cause chronic disabling postprandial abdominal pain, weight loss, and consequently lethargy and social deprivation (3,8). The majority of these patients have had a long medical journey before the diagnosis MALS is considered resulting in a substantial burden of disease and high healthcare and societal costs. Although a Systematic Review have shown a sustainable symptom relief of 68% and a significant and durable improvement of quality of life after surgical treatment for MALS (4), there is still no (inter)national consensus on the existence and treatment of MALS (1, 5, 6, 7). Two recent guidelines (3, 8) concluded that patients with MALS might be considered for surgical CA release (Recommendation 25 GRADE 2D; expert agreement 96%, Terlouw 2020). To end the ongoing debate and to enable the development of evidence-based guidelines for the management of MALS, both guideline committees recommend to perform a blinded, randomised controlled trial comparing a CA release with a sham operation. The proposed Coeliac Artery Release or Sham Operation study will either underline the usefulness of eCAR as a minimal invasive (cost)effective treatment for MALS or it will prohibit a meaningless intervention in patients with disabling abdominal symptoms. If the CARoSO study proves that the treatment of MALS by eCAR is effective, to 490 patients with chronic disabling abdominal symptoms per year can be treated in the Netherlands. Effective treatment of MALS is expected to result in mean health gain of 6.05 Quality Adjusted Life Years (QALYs)/patient and has the potency to reduce the substantial productivity loss and healthcare consumption caused by MALS, resulting in a saving up to M€4.3/year. The outcome of the CARoSO study will be translated into strong recommendations in the coming updates of the relevant (inter)national multidisciplinary guidelines and will be adapted in daily practice.

NCT ID: NCT05390658 Recruiting - Clinical trials for Extracorporeal Membrane Oxygenation Complication

Risk Factors Analysis for Acute Myocardial Infarction Patients

Start date: January 11, 2020
Phase:
Study type: Observational [Patient Registry]

ECMO has been used to save the lives of many critically ill patients with cardiorespiratory dysfunction as important rescue therapy. Though the proportion of ECMO applied to this population has been increasing year by year, clinical outcomes of AMI remain poor with high in-hospital mortality. Thus, it is necessary to characterize clinical features and investigate potentially modifiable factors contributing to outcomes of AMI patients who received ECMO treatment.

NCT ID: NCT05244629 Recruiting - Stent Thrombosis Clinical Trials

Copenhagen Mesenteric Stent Study - A Randomized Trial of Stent Versus Covered Stent Treatment for Chronic Mesenteric Ischemia

COMESS
Start date: June 2023
Phase: N/A
Study type: Interventional

Chronic mesenteric ischemia (CMI) is often caused by narrowings in the arteries providing blood to the intestines. Endovascular stent placement is considered the preferred treatment for this condition. Guidelines increasingly support the use of so called covered stents (CS) in stead of bare stents (BMS) for this use but the level of evidence for this is limited. Using CS incur additional costs for healthcare short-term but may prevent recurrence of narrowing and symptoms postoperatively benefitting patients and healthcare. Study Objective: To evaluate the outcomes after stenting of mesenteric arteries using BMS or CS. Study Outcome: Primary stent patency 1 year after placement The trial will also evaluate complications, how often stents need to be reoperated, Quality of Life (QoL) and reasons for subjects death Method: This is a so called prospective, randomized controlled trial comparing CS vs. BMS. This means that one patients have agrred to treatment they will be randomly selected for treatment with either CS or BMS . The stent metal structure is identical in the two implants and the only difference is the graft covering, making this study unique. The study will also collect blood samples for a biobank that will be used to study markers of disease and how these effect treatment outcomes. All patients referred to the Department of Vascular Surgery due to CMI are considered for inclusion if they havechronic symptoms consistent with CMI, significant stenosis or occlusion of the superior mesenteric artery and are > 18 years Subjects not able to provide informed consent or who have non atherosclerotic cause of CMI, signs of acute loss of blood flow to the intestines cannot participate. Previous stent treatment in the superior mesenteric artery, pregnancy, allergies to contrast or stent materials are also reasons for not being included in this trial. Side effects, risks and disadvantages for participants The risk for procedure-related complications is less than 5% and similar in both study groups. Most short-term complications are related to vascular access sites and consist of local bleeding and thrombosis. Other potential complications include impaired renal function due to contrast use, contrast allergy, arterial dissection and death.

NCT ID: NCT05218863 Completed - Clinical trials for Acute Mesenteric Ischemia

Incidence, Diagnosis, Management and Outcome of Acute Mesenteric Ischemia

AMESI
Start date: June 6, 2022
Phase:
Study type: Observational

This is a prospective, multicentre observational study screening all adult patients admitted to a participating hospital over a 6-month study period (may be adjusted to 4-8 months according to recruitment) and including all patients with suspicion of or confirmed acute mesenteric ischaemia (AMI). Only admission data and hospital mortality outcome will be collected for patients in whom suspicion of AMI is not confirmed. For patients with confirmed AMI full data collection regarding diagnostics, management and long-term outcome is required. Investigators aim to recruit 40-50 sites with expected median of 10-20 patients with confirmed AMI per site during the study period (naturally depending on the size of the hospital). The start of the study is planned for Spring 2022. The aim of the study is to identify the incidence of AMI and its different forms in adult hospitalized patients, and to describe patient characteristics (demographic, clinical and laboratory) at baseline, applied diagnostics and management, as well as outcomes in patients with AMI. An additional aim is to compare the baseline characteristics and outcomes of patients with confirmed AMI to those of patients with suspected AMI in whom the diagnosis was not confirmed.

NCT ID: NCT05194527 Recruiting - Diagnoses Disease Clinical Trials

The Detrimental Course of Acute Intestinal Ischemia

TACTIC
Start date: September 15, 2020
Phase:
Study type: Observational

Rationale: Acute intestinal ischemia is a life-threatening condition with a short-term mortality that can range up to 80%. Medical diagnosis and treatment have remained troublesome, due to the clinical presentation which is mostly characterized by non-specific signs and symptoms. Early unambiguous diagnosis of acute intestinal ischemia is critical to prevent progression from reversible to irreversible intestinal injury, and henceforth decrease morbidity and improve survival. Objective: We aim to validate a panel of plasma biomarkers and investigate volatile biomarkers that allow early and accurate identification of acute intestinal ischemia in patients. In addition, we aim to identify a volatile organic compound (VOC) profile specific for acute intestinal ischemia in exhaled breath. Study design: Prospective observational study Study population: All patients suspected of acute intestinal ischemia Main study parameters: The primary endpoint of the study is the early and accurate identification of presence and severity of acute intestinal ischemia in patients. The main study parameters are plasma biomarkers indicative for intestinal damage and volatile organic compounds (VOC) in exhaled air of patients suspected of acute intestinal ischemia. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: There is a minimal amount of risks involved in participating in this study. Blood samples will be obtained with the use of an arterial line, intravenous line (IV), central venous catheter (CVC), peripheral venous catheter (PVC) or a venepuncture. The risk of venepuncture is a small local hematoma. In addition to blood sampling, we will also obtain exhaled air. This non-invasive procedure takes approximately 5 minutes in which patients breath in a 3L Tedlar bag at a normal frequency and volume. This procedure will not cause any physical strain. Collection of samples and data will take place during the hospital stay of the included patients. For this reason, no additional hospital visits are required for this study. Participating patients in this study will have no direct benefits, but in the future the results of our study will likely be useful in the early diagnosis of patients suspected of acute intestinal ischemia. The research goal in this study is the early identification of patients that suffer from acute intestinal ischemia. These patients are difficult to diagnose due to a multitude of non-specific symptoms and the lack of fast and specific tests. In this study we will be able to investigate patients that are admitted with acute abdominal complications and observe them in the early stages of their condition. Accordingly, we will be able to evaluate the proposed panel of biomarkers and to identify VOC patterns in patients with acute abdominal complications.

NCT ID: NCT04985981 Suspended - Colorectal Cancer Clinical Trials

The Prediction of Anastomotic Insufficiency Risk After Colorectal Surgery (PANIC) Study

Start date: April 1, 2021
Phase:
Study type: Observational [Patient Registry]

The Prediction of Anastomotic Insufficiency risk after Colorectal surgery (PANIC) study aims to establish a machine-learning-based application that allows for accurate preoperative prediction of patients at risk for anastomotic insufficiency after colon and colorectal surgery.

NCT ID: NCT04867499 Completed - Clinical trials for Acute Mesenteric Ischemia

Epidemiology of Acute Mesenteric Ischemia

Start date: October 5, 2021
Phase:
Study type: Observational

Retrospective population-based study on epidemiology of acute mesenteric ischemia in Estonia Study objective is to describe epidemiologic features in adult patients with acute mesenteric ischemia during years 2016-2020. Patients from all hospitals in Estonia are included.

NCT ID: NCT04794959 Not yet recruiting - Clinical trials for Tomography, X-Ray Computed

A Pilot Study on the Using a Newer Computed Tomography (CT) Based Technique for the Detection of Altered Bowel Blood Flow Among Patients Suffering From Chronic Mesenteric Ischemia During Meal Digestion.

Start date: May 2021
Phase: N/A
Study type: Interventional

Chronic meseteric ischemia (CMI) is a disease characterized by an insufficient blood supply to the intestines due to a narrowing (stenosis) of one or multiple intestinal arteries. The primary symptom is abdominal pain especially during meal digestion. Currently the diagnosis of CMI is heavily reliant on the exclusion of differential diagnoses. With this study we wish to evaluate whether a newer CT technology called dual-energy CT (DECT) may be able to visualize this altered blood flow during meal consumption.

NCT ID: NCT04746534 Recruiting - Mesenteric Ischemia Clinical Trials

Cohort SURVI : Intestinal Ischemia and Vascular Diseases

Survibase
Start date: November 27, 2020
Phase:
Study type: Observational

The first Intestinal Vascular Emergency Unit (SURVI), with the institutional support of AP-HP, opened on 4 January 2016, within the Paris-Nord Val de Seine University Hospital Group. This intensive care is dedicated to the management of mesenteric ischemias (acute mesenteric ischemias, chronic mesenteric ischemias) and Intestinal Vascular Diseases Without Ischemia. The organisation of this type of dedicated centre, combining advances in resuscitation, interventional radiology and knowledge of intestinal vascular diseases, has led to a radical change in the prognosis for acute mesenteric ischaemia with a survival rate of over 80% and an intestinal resection rate of less than 40%. Acute mesenteric ischaemia (AMI) is characterised by the combination of digestive distress and vascular insufficiency: occlusive (thrombosis, embolism, arterial, venous) or non-occlusive (low flow or vasospasm). The vital prognosis is catastrophic in the absence of treatment (the mortality rate of an intestinal infarction is almost 100% without treatment), and the functional and anatomical after-effects are major for the survivors. Many intestinal vascular diseases have been identified as providing acute and chronic mesenteric ischaemia. The nosological framework of these diseases is broad, ranging from constitutional diseases of the vessels (collagenosis, arcuate ligament syndrome) to acquired diseases of a thrombophilic, cardiac, degenerative, autoimmune, iatrogenic, traumatic nature... The rarity of these diseases (with the exception of atherosclerotic disease, the incidence of which is increasing with the ageing of the population) makes their level of knowledge insufficient. The natural history of vascular diseases without ischaemia (rate of acute and chronic mesenteric ischaemia, mortality rate, resection rate...) is currently not described. The construction of a longitudinal observational cohort is necessary for the prevalence of ischaemic complications and predictive factors.

NCT ID: NCT04671979 Completed - Mesenteric Ischemia Clinical Trials

Serum Lactate in Acute Mesenteric Ischemia

Start date: May 2, 2017
Phase:
Study type: Observational [Patient Registry]

Background: Acute mesenteric ischemia is a vascular emergency with high mortality because of ambiguous symptomatology and a lack of early diagnostic markers. Lactate dehydrogenase has been described as a mortality biomarker and bowel necrosis length too. Nevertheless, the association between them has been mildly studied. Our objective was to evaluate the association between serum lactate admission levels, bowel necrosis extension, and mortality. Additionally, we performed a mortality characterization. Materials and Methods: A retrospective cross-sectional study was designed. We reviewed patients' clinical records with acute mesenteric ischemia that attended a hospital between 2012 and 2018. We compared serum lactate admission levels with bowel necrosis length and mortality. A receiver operating characteristic curve was performed on the last association. As post hoc analysis, a classification and regression tree on mortality was fitted.