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Constriction, Pathologic clinical trials

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NCT ID: NCT06283940 Not yet recruiting - Clinical trials for Aortic Valve Stenosis

Exercise-based Cardiac Rehabilitation in Patients With Aortic Stenosis After Transcatheter Aortic Valve Implantation

TAVI
Start date: August 2024
Phase: N/A
Study type: Interventional

Aortic valve stenosis (AS) is the most common valve disease among older individuals. In symptomatic AS, mortality is high, and the only treatment that improves prognosis and survival is transcatheter aortic valve implantation (TAVI). TAVI is a growing treatment in Sweden, allowing previously inoperable older patients with AS, who are often frail and have comorbidities, to receive intervention. This results in the need for postoperative cardiac rehabilitation for patients treated with TAVI. Previous systematic reviews and meta-analyses examining the effect of physiotherapist-led exercise-based cardiac rehabilitation (PT-X) after TAVI have shown that participation in PT-X can improve physical fitness (the highest measured oxygen uptake (VO2peak)), walking distance, walking speed, and health-related quality of life (HR-QoL). However, the included studies are limited, and there is selection bias, resulting in low evidence. Therefore, access to PT-X is currently almost non-existent in Sweden. As more patients undergo TAVI, it is crucial to investigate whether PT-X after TAVI can further improve physical fitness, HR-QoL, and reduce hospital admissions in older individuals with AS. Objective: Primary, to investigate whether participation in PT-X after TAVI can impact physical fitness, physical activity level, and health-related quality of life. Secondary, to study the prevalence of frailty and the number of hospital admissions during the first postoperative year after TAVI. Expected outcome: If patients with AS who have undergone TAVI can improve physical fitness, it could potentially strengthen the evidence and optimize the patient's physical capabilities. Increased access to PT-X and awareness of frailty in these patients could reduce the risk of falls and possibly the number of hospital readmissions. This would decrease healthcare consumption and improve the patient's quality of life.

NCT ID: NCT06281041 Active, not recruiting - Clinical trials for Coronary Artery Disease

Nationwide Cohort Study of Antiplatelet Agents as Primary Prevention

NHIS
Start date: January 1, 2013
Phase:
Study type: Observational

There is no specific recommendation regarding pharmacologic treatment as primary prevention for patients with intermediate coronary artery stenosis whose revascularization was deferred based on negative fractional flow reserve (FFR). Current nationwide cohort study conducted using Korean National Health Insurance Service database evaluated the safety and efficacy of antiplatelet therapy in patients with intermediate coronary artery stenosis with deferred revascularization based on negative FFR (FFR>0.80).

NCT ID: NCT06277531 Recruiting - Pancreas Cancer Clinical Trials

Evaluation of diagnostiC Capacity of eccDNAs as Biomarkers in Indetermined biLiary Stricture(ECCBILE)

ECCBILE
Start date: March 1, 2024
Phase:
Study type: Observational [Patient Registry]

Biliary stricture is mainly malignant in the adults and caused by several types of fatal malignancies such as pancreatic cancer, cholangiocarcinoma, and metastatic tumor, which have poor prognosis that the overall survival of unresectable lesions is no more than 15 months. The poor outcome often relates to a lack of reliable strategies for early diagnosis, which results in most patients with malignant biliary stricture being already advanced-stage disease at presentation. Therefore, it is critical to discover novel and effective strategies for the early diagnosis of malignant biliary strictures. Brush cytology and biopsy during endoscopic retrograde cholangiopancreatography (ERCP) are the main methods for recognizing malignant diseases of the bile duct, but their sensitivity is relatively low, 45% and 48.1%, respectively. Even when combined with other biomarkers like carbohydrate antigen 19-9 (CA19-9), their sensitivity is still less than 80%. In the previous study, the investigators found that bcf-eccDNA has excellent diagnostic value in predicting uncertain bile duct stricture, and the sensitivity and specificity of a related eccDNA in 40 samples are 80.8% and 100%. The sensitivity and specificity of another eccDNA were 92.3% and 92.9%, respectively. However, the sample size is still relatively small, and further prospective studies are needed to evaluate its diagnostic efficacy.

NCT ID: NCT06275269 Not yet recruiting - Subglottic Stenosis Clinical Trials

Endoscopic Mucosal Injection Versus Ultrasound-Guided Injection of Triamcinolone to Treat Subglottic Stenosis

Start date: March 10, 2024
Phase: N/A
Study type: Interventional

This study employs a multicenter, randomized controlled trial method, where patients meeting the inclusion criteria for subglottic stenosis are randomly divided into two groups. These groups are respectively undergoing translaryngeal endoscopic mucosal injection and ultrasound-guided injection of triamcinolone treatment. The comparison will focus on various indicators such as therapeutic effect, incidence of adverse reactions, treatment costs, and hospital resource utilization between the two groups. The safety and effectiveness will be compared to determine the relative merits of the two treatment methods.

NCT ID: NCT06260969 Recruiting - Clinical trials for Acute Ischemic Stroke

Endovascular Treatment of Acute Ischemic Stroke With Underlying Intracranial Artery Stenosis

Start date: September 1, 2022
Phase:
Study type: Observational [Patient Registry]

The study is a prospective multicentre registry study. Patients admitted to 10 stroke centres nationwide from September 2022 to September 2025 with acute ischaemic stroke due to large vessel occlusion considering underlying ICAS and treated with emergency endovascular thrombolysis were included for analysis. Patients who met the general inclusion criteria underwent thrombectomy and the necessary remedial treatment.

NCT ID: NCT06238518 Recruiting - De Novo Stenosis Clinical Trials

Intravascular Lithotripsy Versus Conventional Therapy for Severely Calcified Coronary Artery Lesions

REC-CHIPCAC
Start date: January 5, 2024
Phase: N/A
Study type: Interventional

Percutaneous coronary intervention (PCI) encounters challenges with calcified coronary lesions, leading to potential issues such as failed balloon dilatation, incomplete stent expansion, and increased risks of adverse events post-PCI, including stent restenosis and thrombosis. Intravascular lithotripsy (IVL), a novel approach for severely calcified coronary lesion preparation, has shown promising preliminary outcomes. Combining IVL with conventional approaches, such as Rotational atherectomy (RA), non-compliant balloons, or cutting balloons, may associated with additional benefit than conventional approaches only in terms of better stent expansion and lower long-term adverse events. This pilot randomized trial aims to investigate whether combining IVL to conventional therapy surpasses the efficacy of conventional approaches alone. The primary effectiveness endpoint is final stent expansion assessed by post-procedure optical coherence tomography (OCT), and the primary safety endpoint is target lesion failure (TVF). The trial seeks to provide valuable insights into the optimal approach for managing severely calcified coronary lesions during PCI.

NCT ID: NCT06235385 Not yet recruiting - Clinical trials for Aortic Valve Stenosis

European Association of Cardiovascular Imaging Multiple and Mixed Valvular Disease Study

EACVI-MMVD
Start date: February 1, 2024
Phase:
Study type: Observational

This study aims to investigate the prevalence and characteristics of multiple and mixed valvular heart disease (MMVD), which includes combinations of stenotic or regurgitant lesions on cardiac valves. The research will be conducted as a multicenter observational study, involving several centers worldwide, and will have a one-year follow-up period (with a possible extension to 5 years). The primary aim is to determine the proportion of MMVD among patients evaluated for valvular heart disease. Secondary aims include the evaluation of the epidemiologic distribution of clinical, biological, and cardiovascular imaging characteristics at baseline, management strategies, and their impact on prognosis. The study will also evaluate clinical outcomes such as mortality, hospitalization for heart failure, and changes in echocardiographic parameters. This research aims to provide valuable insights into the diagnosis, management, and prognosis of MMVD, addressing an important knowledge gap in this area.

NCT ID: NCT06232005 Completed - Urethral Stricture Clinical Trials

Intralesional Injection of Mitomycin C Following Visual Internal Urethrotomy for Recurrent Urethral Stricture

Start date: January 1, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

To evaluate the effectiveness of administering mitomycin C through intralesional injection after performing visual internal urethrotomy (VIU) for the treatment of recurring urethral stricture.

NCT ID: NCT06215378 Not yet recruiting - Clinical trials for Aortic Valve Stenosis

Antagonization of Heparin With Protamine Sulfate After TAVI

ATLANTIS-Prota
Start date: February 1, 2024
Phase: Phase 3
Study type: Interventional

Transcatheter aortic valve replacement (TAVR) is now the first therapeutic option offered to high and intermediate risk patients with symptomatic aortic stenosis but even to low-risk, when the aortic valve is tricuspid and the transfemoral approach is suitable. Vascular and bleeding complications are the most frequent procedure-related unwanted events associated with increased short-term morbidity and mortality. Selection of the appropriate vascular access site and pre-closing devices as well as stent implantation mitigate these complications. ACT-guided heparin reaching a target of 300 seconds or more is recommended prior to the placement of the guiding sheath in the common femoral artery. Protamine sulfate is the heparin antidote, which antagonizes 100% of its anti-IIa activity and 60% of its anti-Xa activity. Reversal of heparin using protamine sulfate is recommended for transapical and complicated transfemoral aortic valve placement.However, there is a great heterogeneity of protamine use in daily practice and supportive evidence for the prevention of bleeding complications as well as its safety is lacking. In addition, the radial approach for the second vascular access is more commonly used as well as the use of echo-guided femoral puncture further questioning reversal of heparin when the procedure has been successfully completed without overt bleeding complications. Our study aims to demonstrate the superiority of a strategy of systematic ACT-guided heparin administration followed by systematic antagonization with protamine sulfate over usual of care to reduce in-hospital mortality, vascular/bleeding complications, stroke and transcient ischemic attack, myocardial infarction or red blood cell transfusion, from randomization to hospital discharge

NCT ID: NCT06212050 Enrolling by invitation - Aortic Stenosis Clinical Trials

Feasibility, Safety, and Effectiveness of the ACURATE neo2 Transcatheter Heart Valve for Severe Bicuspid Aortic Stenosis

Neo2BAV
Start date: September 15, 2023
Phase:
Study type: Observational

The goal of the NEO2 BAV registry is to investigate the safety, effectiveness, and clinical performance of TAVI using the ACURATE neo2 valve in patients with severe BAV stenosis. The clinical, procedural, and imaging characteristics will be collected from patients with severe BAV stenosis, regardless of the phenotype, and treated with TAVI using the ACURATE neo2 bioprosthesis worldwide.