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Calcinosis clinical trials

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NCT ID: NCT05259046 Recruiting - Arterial Stiffness Clinical Trials

The InterVitaminK Trial - Effects of Vitamin K Supplementation on Cardiovascular, Metabolic, and Bone Health

InterVitaminK
Start date: June 21, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to examine the effect of menaquinone-7 (MK-7) supplementation on cardiovascular, metabolic, and bone health.

NCT ID: NCT05162742 Recruiting - Clinical trials for Cardiovascular Diseases

Colchicine and Inflammation in Aortic Stenosis

CHIANTI
Start date: December 22, 2022
Phase: Phase 3
Study type: Interventional

Aortic stenosis (AS) is the most common valvular heart disease in the developed world. Once symptomatic, untreated patients have a poor prognosis with five-year survival rate of 25%. Once at an advanced stage, AS will lead to the development of left ventricle hypertrophy, and eventually heart failure and death. At-present, there is no effective medical therapy for aortic stenosis. Current management of patients with AS consists of 'watchful waiting'. Valve replacement is needed when these patients (often acutely) become symptomatic. Recent studies have shown that inflammatory processes with similarities to atherosclerosis play an important role in AS. Therefore, we hypothesize that treatment with anti-inflammatory therapy, in the form of colchicine, could reduce the progression of AS. If positive, this trial will be the first to provide a potential therapeutic option for millions of people world-wide with AS.

NCT ID: NCT05046301 Recruiting - Breast Carcinoma Clinical Trials

Contrast-Enhanced Mammography for the Evaluation of Mammographic Microcalcifications

Start date: March 23, 2021
Phase:
Study type: Observational

This clinical trial evaluates the added role of contrast-enhanced mammography (CEM), as well as imaging and blood biomarkers, for predicting the presence or absence of high-grade ductal carcinoma in situ (DCIS) or invasive cancer on pathology. Screening mammography is the mainstay of population-wide early breast cancer detection, and mammography-detected cancers are usually of an earlier stage, giving women the best chance of survival. However, the main drawbacks of this type of screening are false positive results and potential over-diagnosis of breast cancer. Suspicious microcalcifications detected with mammography pose a particular diagnostic problem, as they may be associated with invasive and high-grade in-situ cancers like DCIS, but are more often benign or require further workup to verify diagnosis. As such, microcalcifications detected by mammography pose a risk of both over-diagnosis and underestimation of disease severity. This study evaluates the impact of using CEM, compared to standard full field digital mammography (FFDM) for the management of suspicious microcalcifications and prediction of breast cancer in women with this finding.

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: 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: 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.

NCT ID: NCT04583462 Recruiting - Type 1 Diabetes Clinical Trials

Impact of Metformin on Peripheral Arterial Calcification in Type 1 Diabetes

IMPACT-1D
Start date: June 2, 2021
Phase: Phase 3
Study type: Interventional

Vascular calcification (VC) is a complication frequently observed in elderly, in chronic kidney disease (CKD) and in diabetes (particularly in type 1 diabetes). VC is a dynamic pathophysiological process that causes cardiovascular morbidity and is an independent risk factor of major amputation. In vitro and human observational studies have suggested a role of metformin in preventing VC. The investigators propose to test the effect of metformin treatment during two years on lower limb arterial calcification evaluated by CT-scan in patients with type 1 diabetes and without CKD. This research is a phase III double blind randomized controlled trial consisting of 2 years double-blind treatment phase (patients randomized to metformin or placebo) in type 1 diabetic patients. The participants and the investigators will be blinded to the study medications taken during the double-blind treatment period