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Calcinosis clinical trials

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NCT ID: NCT05404204 Recruiting - Clinical trials for Coronary Artery Disease

The Efficacy and Safety of a Novel Adjunctive Pacing Strategy During Rotational Atherectomy

ROTA-PACE
Start date: February 1, 2021
Phase:
Study type: Observational

Coronary artery narrowings interfere with blood flow to the heart which can cause chest pain and heart attacks. Cardiologists can treat these narrowings with balloons and stents. However, some narrowings can become very calcified and hard making treatment with balloons and stents difficult. Rotational atherectomy is a tool to treat calcific coronary disease. It uses an ablative drill to break down the hardened plaques inside the coronary arteries facilitating subsequent treatment with balloons and stents. However, during this procedure patients can experience a slow heart rate which may compromise procedural safety. Cardiologists may use a temporary pacemaker that is inserted by separately accessing the heart through a large vein usually from the leg. This maintains a safe heart rate throughout the procedure. However, inserting the temporary pacemaker is associated with additional complications. We have developed and propose an alternative strategy to provide a temporary safety pacemaker during rotational atherectomy without the need for inserting an additional pacemaker.

NCT ID: NCT05301218 Recruiting - Clinical trials for Coronary Artery Calcification

CAlcified Lesion Intervention Planning Steered by OCT.

CALIPSO
Start date: December 15, 2021
Phase: N/A
Study type: Interventional

Calcified lesions are very frequent among coronary artery disease stenotic lesions. The prevalence of calcifications ranges from 30 to 40% (by angiography evaluation) but is higher when analyzed by intra coronary imaging. Calcified lesions are very frequent among coronary artery disease stenotic lesions. The prevalence of calcifications ranges from 30 to 40% (by angiography evaluation) but is higher when analyzed by intra coronary imaging. The presence of calcifications increases the risk of adverse evolution after PCI , including stent restenosis, thrombosis and need for repeat revascularisation. Specific and appropriate tools can be used for calcified lesions management , including high pressure non compliant balloons, intravascular lithotripsy and rotablator. Intra vascular OCT has a high sensitivity and specificity for calcium detection among coronary artery lesions. Compared to IVUS, OCT allows a better quantification of calcium sheets (depth extension ) . Several intra coronary imaging based calcified lesions management algorithms have been proposed , but none have been validated in clinical practice.

NCT ID: NCT05275088 Recruiting - Clinical trials for Failed Prosthetic Atrioventricular Valve/ Annulus Repair

Prizvalve® Transcatheter Atrioventricular Valve Replacement Study

Start date: March 9, 2022
Phase: N/A
Study type: Interventional

To evaluate the safety and performance of the Prizvalve® system in patients with severe atrioventricular annular calcification or failed prosthetic atrioventricular valve/ annulus repair.

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: NCT05235568 Active, not recruiting - Clinical trials for Aortic Valve Stenosis

VALVOSOFT® Pivotal Study

Start date: June 15, 2022
Phase: N/A
Study type: Interventional

The objective of the study is to evaluate the safety and performance of a new non-invasive ultrasound therapy (NIUT) with Valvosoft in the treatment of Calified Aortic Stenosis

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: NCT05112250 Completed - Clinical trials for Coronary Artery Calcification

IVL for Stent Underexpantsion

IVL-DRAGON
Start date: November 1, 2019
Phase:
Study type: Observational [Patient Registry]

The IVL-Dragon Registry was a multicenter study that enrolled consecutive patients with stent underexpansion treated with IVL in high-volume PCI centers. The primary efficacy endpoint was clinical success, defined as a reduction of stent underexpansion to <30% with no evidence of in-hospital device-oriented composite end point (DOCE) (defined as a composite of cardiac death, target lesion revascularization, and target vessel myocardial infarction).

NCT ID: NCT05060809 Completed - Clinical trials for Vascular Calcification

Vitamin k1 and Its Relation to Vascular Calcification in Hemodialysis Patients

Start date: January 1, 2018
Phase: Phase 4
Study type: Interventional

Vascular calcification (VC) represents one of the major complications associated with progressive renal impairment. Matrix Gla-protein (MGP) is a vitamin K-dependent protein that acts as a powerful inhibitor of vascular calcification. Despite this fact, it remains unknown whether supplementation with vitamin K can lead to reduction or reversal of vascular and heart valve calcification. Our study aims primarily to investigate the effect of intravenous vitamin K1 three times weekly for a total duration of 6 months on the serum levels of dephosphorylated-uncarboxylated MGP (dp-ucMGP) as well as aortic calcification score and severity of aortic and mitral valve lesions.

NCT ID: NCT05050669 Not yet recruiting - Clinical trials for Generalized Arterial Calcification of Infancy

Natural History Study of ENPP1 Deficiency and and the Early-onset Form of ABCC6 Deficiency

Start date: January 2022
Phase:
Study type: Observational

The purpose of this prospective study is to characterize the natural history of ENPP1 Deficiency (including Generalized Arterial Calcification of Infancy Type 1 [GACI] and Autosomal Recessive Hypophosphatemic Rickets Type 2 [ARHR2]) and the early-onset form of ABCC6 Deficiency (Generalized Arterial Calcification of Infancy Type 2 [GACI-2]) longitudinally.

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.