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Calcinosis clinical trials

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NCT ID: NCT03301558 Withdrawn - Clinical trials for Kidney Transplant; Complications

The Effect of Sodium Bicarbonate (Nephrotrans®) on Calcification Propensity of Serum in Kidney Transplant Recipients

Start date: January 1, 2024
Phase: Phase 2
Study type: Interventional

This is a single-center, prospective, open-label, randomized, cross-over study.

NCT ID: NCT03292354 Completed - Cardiac Disease Clinical Trials

Personalization of CM Injection Protocols in Coronary Computed Tomographic Angiography

PeopleCT
Start date: April 11, 2017
Phase: N/A
Study type: Interventional

Cardiac computed tomography (CCT) is one of the standard non-invasive imaging techniques allowing imaging of the heart and coronary arteries with a high temporal and spatial resolution. The high sensitivity and negative predictive value (NPV) of coronary CT angiography (CCTA) make it a valuable tool in the assessment of coronary artery disease (CAD) in patients with low to intermediate risk for CAD, especially to rule out CAD. This risk stratification can be done with help of multiple different risk-calculators (e.g. the updated Diamond-Forrester model by Genders et al. 2012). These calculators take different variables into account, e.g. advanced age, gender, blood pressure, diabetes mellitus (DM), lipid profile and smoking. The aim of CCTA is a high diagnostic accuracy, which depends on both optimal intravascular enhancement (in Hounsfield Units; minimal 325 HU) and contrast-to-noise ratio (CNR). Optimal intravascular enhancement and CNR depend on different factors such as scan technique (e.g. tube voltage, tube potential), parameters of the administered contrast material (CM) and patient related factors (e.g. cardiac output (CO), body weight (BW)). Patients with cardiac diseases often have multiple risk factors for developing contrast induced nephropathy (CIN), e.g. diabetes mellitus, advanced age, hypertension and chronic kidney disease. Although the relationship between CTA and CIN has recently come to discussion (AMACING trial; Nijssen et al. 2017), it is still desirable to minimise the CM volume used in these patients. One method to reduce the CM volume is to personalise the injection protocols. The personalisation of injection protocols to the individual patient is gaining more attention in the field of CT imaging. The goal is to individualise the injection protocols to a level, where the patient only receives the minimal amount of CM needed to acquire a diagnostic scan, while maintaining a diagnostic image quality. Many techniques are available and have been studied, e.g. adjustment of CM volume to scan protocol, CO, lean body weight (LBW) and BW. However, no data is available on which of these is the most beneficial method for the personalisation of CM injection protocols. Therefore, the aim of this study is to assess the performance of three different personalized injection protocols (based on CO, LBW and BW) in CCTA with regard to image quality in comparison to previously used protocols in our department. We hypothesize that the personalized injection protocols will be non-inferior, provide a homogenous coronary enhancement (less non-diagnostic scans) in patients, and will account for a reduction of CM volume in our department in comparison to the previously used protocols.

NCT ID: NCT03292029 Completed - Clinical trials for Cardiovascular Diseases

Pilot Medical Evaluation of the T50 Test

Start date: September 22, 2017
Phase: N/A
Study type: Interventional

This pilot study aims to evaluate in an exploratory way the predictive power of a novel in vitro test (T50 Calcification Inhibition Test, T50 CIT), which measures the mineralization inhibition capacity of blood, in terms of its association with time to all-cause mortality in haemodialysis patients.

NCT ID: NCT03267277 Completed - Dermatomyositis Clinical Trials

Sodium Thiosulfate for Treatment of Calcinosis Associated With Juvenile and Adult Dermatomyositis

Start date: October 5, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

Background: Dermatomyositis (DM) and juvenile dermatomyositis (JDM) cause inflammation in the muscles. People with DM and JDM can develop calcium deposits in places they should not, known as calcinosis. Calcinosis can be painful and cause disabilities and other problems. Researchers want to learn more about calcinosis to find treatments for it. Objective: To test if sodium thiosulfate (STS) can treat people with DM with calcinosis. Eligibility: People ages 7 and older who have moderate or severe calcinosis. They must have stable DM and calcium deposits in the torso or at least 2 limbs. Design: Participants will be screened with: - Medical history - Physical exam - Muscle strength and function tests - Blood and urine tests Participants will have several visits: - 7-day pre-treatment visit about 10 weeks before starting STS - Treatment visits over 10 weeks. They will get STS 3 times a week through IV infusion. They may be hospitalized the whole time. If they tolerate the drug, they may be discharged at certain times. During these times, they will return for the infusions. - 3- to 5-day post-treatment visits 24 weeks and 62 weeks after starting STS. Visits may include repeats of screening tests and: - Questionnaires - Scans: They lie in a machine that takes pictures of the body. They may be injected with a radioactive agent. - Durometry: A small instrument applies pressure on the skin or exposed calcinosis. - Measurements of blood flow in the arms and fingernail blood vessels - Photographs of the skin - Kidney ultrasound - Tests of kidney function - Calcinosis aspiration: A needle placed into areas of calcinosis removes liquid.

NCT ID: NCT03169400 Not yet recruiting - Oxidative Stress Clinical Trials

Theranova Dialyzer and Chronic Kidney Disease - Mineral Bone Disorder (CKD-MBD)

Start date: October 1, 2017
Phase: N/A
Study type: Observational [Patient Registry]

The project will be structured in 3 main parts: 1. Effect of sera of ESRD patients on HD using Theranova dialyzer on high-Pi induced vascular calcification in an in vitro model of rat VSMCs. 2. Effect of sera of ESRD patients on HD using Theranova dialyzer on oxidative stress pathways in an in vitro model of rat VSMCs vascular calcification. 3. Study of RNA sequencing, transcriptome analysis gene expression of time course high-P challenged VSMCs studying the effect of sera of ESRD patients on HD using Theranova dialyzer

NCT ID: NCT03104166 Completed - Clinical trials for Vascular Calcification

Modulation of Vascular Calcification in Chronic Dialysis Patients

ModuVas
Start date: January 22, 2018
Phase: N/A
Study type: Interventional

50 patients will be randomized and treated with MCO or highflux dialysis for six months (24 weeks) after a run-in phase of 4 weeks Highflux treatment. Serum samples will be drawn at baseline, after 4, 8 and 24 weeks. Later, calcifiying vascular smooth muscle cells will be incubated with these serum samples and calcification will be assessed with Alkaline phosphatase and Alizarin staining. Primary endpoint: In vitro Calcification of coronary vascular smooth muscle cells (Alkaline Phosphatase/ WST8) after six months Calcifiying vascular smooth muscle cells will be incubated with serum samples obtained after six months of MCO/HF dialysis and calcification will be assessed with Alkaline phosphatase and WST8. Secondary Endpoints: Aortic Pulse wave velocity after 6 months Calcification propensity after 6 months Physical activity level after 6 months Cell culture: Incubation of VSMC with serum samples obtained after 6 months - Alizarin staining/WST-8 - Measurement of calcification inhibitors Osteopontin and Matrix Gla Protein in Supernatants - Apoptosis The treatment regimen of the patients will not be altered, hence blood flow, dialysate flow as well as dialysis time will remain constant.

NCT ID: NCT03088787 Recruiting - Clinical trials for Aortic Stenosis, Calcific

Feasibility of Continuous Noninvasive Finger Arterial Blood Pressure Measurement for Detection and Staging of Aortic Stenosis

COaRt
Start date: April 1, 2017
Phase:
Study type: Observational

The primary purpose of this study is electronic data collection of arterial pressure waveform signals in patients with Aortic Stenosis. The collected digital pressure waveform data will be used to assess the feasibility of using the arterial pressure signal as a decision support tool for early detection of aortic stenosis conditions. Furthermore we evaluate hemodynamic parameters before and after valve repair and its correlation with outcome.

NCT ID: NCT03070860 Completed - Clinical trials for Pseudoxanthoma Elasticum

What's Happen Under the Calcification Process in Pseudoxanthoma Elasticum

GOCAPXE
Start date: November 2016
Phase: N/A
Study type: Interventional

The investigators hypothesize is that in PXE patients, low grade chronic inflammation could preceed the molecular and the clinical calcification process.

NCT ID: NCT03031561 Completed - Breast Carcinoma Clinical Trials

Ultrasound Imaging Technique in Detecting Breast Microcalcifications in Patients Undergoing Biopsy for a Breast Abnormality

Start date: March 1, 2012
Phase: N/A
Study type: Interventional

This clinical trial studies a new type of ultrasound technique, MicroPure, in detecting breast microcalcifications in patients undergoing biopsy for a breast abnormality. Ultrasound sends sound waves into the body, and the sound waves reflected back are interpreted by the machine into a grayscale image. MicroPure uses a filter that adjusts the brightness and gives color to the ultrasound images, which may allow doctors to better identify microcalcifications. Microcalcifications are tiny deposits of calcium in the breast that cannot be felt but can be detected by imaging. A group of microcalcifications may indicate that cancer is present.

NCT ID: NCT03010072 Completed - Clinical trials for Endstage Renal Disease

The Effect of Phosphate Lowering Using Sucroferric Oxyhydroxide (PA21) on Calcification Propensity of Serum

Start date: June 9, 2017
Phase: Phase 2
Study type: Interventional

This is a single-center, prospective, open-label, controlled, randomized, cross-over study in 34 prevalent end-stage renal disease patients on chronic hemodialysis treatment with hyperphosphatemia.