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Calcinosis clinical trials

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NCT ID: NCT05030831 Active, not recruiting - Clinical trials for Pseudoxanthoma Elasticum

Evaluation of Safety, Tolerability, and Efficacy of INZ-701 in Adults With ABCC6 Deficiency Causing PXE

Start date: April 11, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics PD) of multiple ascending doses of INZ-701, an ectonucleotide pyrophosphatase/phosphodiesterase 1 (ENPP1) recombinant fusion protein, for the treatment of ABCC6 Deficiency. The goal of the study is to identify a dose regimen for further clinical development in the treatment of ABCC6 Deficiency.

NCT ID: NCT04983875 Recruiting - Clinical trials for Vascular Calcification

Mammography and Breast Arterial Calcification: An Information-Sharing Trial

Start date: September 29, 2021
Phase: N/A
Study type: Interventional

The purpose of this research study is to determine the potential benefits of adding information on patients' breast arterial calcification (BAC) results to the standard results letter women receive after mammography. In addition to looking for potential breast cancer, research shows that mammograms can also detect the presence of calcifications within the breast arteries. Those calcifications can be associated with coronary artery disease. Right now, women are not routinely told whether or not they have BAC; that is, it's not part of standard practice to communicate that information to patients. However, previous research has suggested that patients would like to be informed about their BAC status more often. In this study, the team has two goals. First, the team wants to measure the rates of BAC in a large, diverse group of 14,875 women. Because most of the past research on BAC has largely been focused on White mammography patients, the researchers feel it is important to see if the results are similar or different in a more racially and ethnically diverse sample. Second, the study team wants to understand the effects of giving women information on their BAC results as part of their standard post-mammography letter. Specifically, the study team wants to see how sharing that information might affect women's healthcare choices and lifestyle. The research will include 1,888 women in this second part of the study, which will be the first in the literature to explore women's reactions to BAC information. If research shows that women find the information useful, BAC information may be given to women regularly in the future.

NCT ID: NCT04966416 Not yet recruiting - Systemic Sclerosis Clinical Trials

Calcinosis Reduction by Pyrophosphate in SSC

Start date: August 1, 2023
Phase: N/A
Study type: Interventional

Calcinosis, i.e. crystal-like nodules are troublesome complication of systemic sclerosis, an autoimmune disease. Pyrophosphate inhibits its formation is laborytory. We would like to test if orally administered pyrophosphate prevents calcinosis formation.

NCT ID: NCT04956120 Active, not recruiting - Clinical trials for Vascular Calcification

Effect of Citrate Dialysis on Vascular Calcification

Start date: June 2, 2021
Phase: N/A
Study type: Interventional

The goal of this study is to determine whether hemodialysis with citrate slows the progression of vascular calcification. Participants will be dialyzed with one of two standard dialysis solutions, one with and one without citrate, for 12 months and then switched to the other solution for 12 months. Vascular calcification will be measured on mammograms that will be performed at 6-month intervals and additional blood samples will be obtained at 6-month intervals.

NCT ID: NCT04889053 Recruiting - Type 2 Diabetes Clinical Trials

Coronary Artery Calcification in Type 2 Diabetes Mellitus (USCAC Study)

Start date: June 1, 2021
Phase:
Study type: Observational

Coronary artery calcification (CAC) is a common complication of type 2 diabetes mellitus(T2DM), which can significantly increase all-cause mortality and the incidence of serious cardiovascular events, and increase the burden of the national economy. The epidemiological characteristics and the clinical progress of CAC are still not clear. Moreover, the pathogenesis of CAC has not yet been fully elucidated, and lack of specific diagnostic indicators. Arterial calcification is an active, reversible, and multifactorial biological process like bone formation. It is generally believed that early detection of calcification lesions and active targeted treatment may be the key to prevention and treatment of vascular calcification. In addition, statins are commonly used in patients with dyslipidemia and can stabilize CAC plaque. However, the timing, dosage and effect of statins are controversial. Moreover, our previous study found that the expression of miR-32 is significantly elevated in patients with CAC, and can promoting vascular calcification. Herein, this study is to conduct a prospective cohort study on T2DM patients with CAC in Hunan province through a multidisciplinary and multi-center cooperation model, the main research objectives include the following three parts: ① To identify the prevalence, incidence, and characteristics of CAC in T2DM patients in Hunan province, and to build a risk assessment model. ② To observe the effects of statins on the occurrence and development of CAC in patients with T2DM, and to provide clinical data for the improvement of medication guidelines; ③To observe the dynamic changes of serum miR-32 in the progression of CAC in patients with T2DM, and to explore its possibility as a serological diagnosis or prognostic bio-maker of CAC. The completion of this research project is expected to bring a new breakthrough in the field of early diagnosis, prognosis evaluation, and intervention treatment of patients with T2DM combined with CAC, and provide an important reference for the formulation of cardiovascular disease prevention and control strategy.

NCT ID: NCT04862429 Recruiting - Breast Cancer Clinical Trials

Biopsy of Calcifications Under Contrast Enhancement Guide (BoCCE)

BoCCE
Start date: July 24, 2021
Phase: N/A
Study type: Interventional

Calcification clusters are 30-40% of recalls in mammographic screening, but have a low positive predictive value (~15%) for ductal cancer in situ (DCIS) or invasive cancer. These calcifications often need histological assessment with stereotaxic guided biopsy (Mammotome). With extended calcifications, choosing the best area to biopsy may be challenging. The main objective of this 1:1 randomized controlled clinical trial is to compare the accuracy of the CESM guide (study arm with biopsy under CESM guidance) with the traditional Mammotome (control arm with biopsy under stereotactic guidance) in conducting the biopsy in the area of greatest malignancy/grade of the lesion, using as gold-standard the histological exam of the operating piece. Women recalled with indication to perform stereotactic biopsy for clusters of suspicious calcifications on mammography (BIRADS R3 or R4 or R5) not mass-associated will be included. Anticipated sample size is 100 women per arm.

NCT ID: NCT04837638 Active, not recruiting - Diet Habit Clinical Trials

Diet Quality and Coronary Artery Calcification in Adults With Heterozygous Familial Hypercholesterolemia

FH-CAC
Start date: July 1, 2021
Phase:
Study type: Observational

The overarching objective is to evaluate the relationship between diet and coronary artery calcification in patients with heterozygous familial hypercholesterolemia (HeFH). We will recruit adults with HeFH. They will have to complete questionnaires on diet, medication and lifestyle. Coronary artery calcification will be measured in each patient using a CT scan. Physiological and biochemical data will be collected.

NCT ID: NCT04753593 Recruiting - Clinical trials for Vascular Calcification

Use of Discarded Surgery Human Tissue Specimens for Basic Science Research

HumTisRes
Start date: March 16, 2021
Phase:
Study type: Observational

Although it is now established that calcification process result from the joint and coordinated action of different cell types, many areas of shadow remain regarding the spatio-temporal implementation of these events. Highlighting these processes requires additional research to consider new approaches to clinical management of patients with such conditions. It is in this context that the investigators need to use residual human tissue fragments resulting from surgery which are not intended to be used for clinical-biological management of patients. The use of these pseudonymised human tissues will allow the investigators to conduct in vitro cell culture experiences.

NCT ID: NCT04742478 Recruiting - Clinical trials for Coronary Artery Calcification

ROVUS Asia Registry (Evaluate Safety and Effectiveness of Rotational Atherectomy and Intravascular Ultrasound for Heavily Calcified Coronary Lesion)

ROVUS
Start date: March 10, 2021
Phase:
Study type: Observational [Patient Registry]

Rotablation with or without other calcium debulking therapies is a safe adjunctive procedure for patients with severe coronary calcification requiring Percutaneous Coronary Intervention (PCI).

NCT ID: NCT04716361 Recruiting - Clinical trials for Femoropopliteal Artery Occlusion

Outcome of Endovascular Therapies in Chronic Femoropopliteal Occlusive Disease With Severe Calcification

Start date: December 10, 2020
Phase:
Study type: Observational

This study is a prospective, multicenter, real world, observational study, which aims at evaluating the safety, efficacy and economic cost of endovascular treatments for endovascular therapies in chronic femoropopliteal occlusive disease with severe calcification. It is estimated that 400 subjects diagnosed with chronic femoropopliteal occlusive disease with severe calcification and receive endovascular treatments will be enrolled in eight centers nationwide from January 2021 to December 2022. All the subjects will be under follow-up for two years. There is no restriction on the endovascular techniques. The primary outcomes include the technical success rate of each endovascular techniques and the reintervention rate driven by lesions' clinical symptoms.