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Coronary Disease clinical trials

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NCT ID: NCT06369142 Not yet recruiting - Clinical trials for Coronary Artery Disease

Intracoronary Stenting and Additional Results Achieved by ShockWAVE Coronary Lithotripsy

ISAR-WAVE
Start date: April 30, 2024
Phase: N/A
Study type: Interventional

The clinical trial is intended to evaluate the efficacy, safety and economic benefit of coronary lithotripsy compared to other additional procedures (cutting or super high pressure balloon angioplasty, ablative procedures) in lesion preparation and interventional treatment of severely calcified coronary stenoses.

NCT ID: NCT06364683 Not yet recruiting - Clinical trials for Coronary Artery Disease

Coronary Artery Disease and Exercise Adherence

Start date: May 13, 2024
Phase:
Study type: Observational [Patient Registry]

This study aims to determine the factors affecting exercise adherence in patients with coronary artery disease (CAD). For this purpose, the following measurement tools will be used respectively: (1) "Patient Information Form" including sociodemographic characteristics of the patients and medical information related to the disease, (2) the Exercise Adherence Rating Scale (EARS), (3) Exercise Self-Efficacy Scale (ESE) and, (4) Turkish-Health Literacy Survey Europe-Q12 (HLS-EU-19-12Q-TR). Statistical analyses will be carried out by descriptive statistics (number, percentage, mean, standard deviation, etc.), correlation analysis and regression analysis.

NCT ID: NCT06358508 Not yet recruiting - Clinical trials for Coronary Artery Disease

Sapphire 3 CTO Study

Start date: June 2024
Phase: N/A
Study type: Interventional

A prospective, open label, multi-center, single arm, observational study designed to evaluate the acute safety and device performance of the Sapphire 3 0.85, 1.0 and 1.25mm diameter coronary dilatation catheter in predilatation of Chronic Total Occlusion (CTO) lesions during percutaneous coronary intervention. One hundred seventy (170) subjects will be enrolled with a target of one hundred fifty-three (153) evaluable subjects by the angiographic core laboratory at up to 15 clinical sites with the Sapphire 3 0.85, 1.0 and 1.25mm diameter PTCA dilatation catheter to pre-dilate CTO lesions in coronary arteries during their index procedure. All subjects will be screened according to the protocol inclusion and exclusion criteria and will be followed through study completion, which is defined as 24-hours post-procedure or hospital discharge, whichever comes first.

NCT ID: NCT06358105 Not yet recruiting - Clinical trials for Coronary Artery Disease

Simulator Training to Improve Interventional Cardiologist Skills (STARTERS) Trial

STARTERS
Start date: November 15, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to learn if simulator-based training will improve interventional cardiology fellows' skills and will improve patient outcomes. The main questions it aims to answer are: - Does this training improve specific operative parameters recorded during initial coronary interventions performed as first operators under senior supervision? - Will major and minor procedural complications be reduced after simulator-based training? Interventional cardiology fellows in their first year of training will be randomized between standard master-apprentice training or simulator-based training before starting their cath lab period. They will be supervised during their cath lab period as first operators by senior interventional cardiologists. During their first 50 procedures performed as supervised first operator, specific procedural data will be collected.

NCT ID: NCT06348875 Not yet recruiting - Clinical trials for Coronary Artery Disease

Clinical Evaluation of Radiation Reduction for Optimized Safety

CERROS
Start date: June 15, 2024
Phase:
Study type: Observational

The primary objective of this study is to determine whether a reduced radiation protocol (RRP) in which angiograms are acquired at ultralow radiation doses and then processed using spatiotemporal enhancement software can produce similar quality angiographic images as compared with standard techniques.

NCT ID: NCT06327984 Not yet recruiting - Clinical trials for Coronary Artery Disease

Barts Sex-CAD Database

Start date: May 2024
Phase:
Study type: Observational [Patient Registry]

There is a lack of understanding of how Coronary Artery Disease (CAD) - meaning the blocking or furring up of the arteries of the heart - starts and progresses in women. In both men and women, CAD is the most common cause of heart attacks, which occur when the blood supply in the heart is interrupted (these are also known medically as 'acute coronary syndromes'). Before the menopause women appear to be protected from CAD; however, after the menopause that protection is lost. Also, those women who do suffer a heart attack have twice the risk of further heart attacks compared to men despite having the same treatment that works well in men. Biological differences between men and women are probably playing an important role in the way CAD develops. However, due to a lack of research there is currently little understanding of how the female body works in this area. Inflammation is the body's natural response to injury or infection. Importantly it is also involved in the development of CAD. Hormones such as oestrogen and testosterone are also likely to be contributory factors. We think the differences between the way these hormones and inflammation play a part in CAD in both men and women are important, but the role they play is not yet fully understood. In this study we wish to measure the 'markers' of inflammation in the blood of patients attending Barts Heart Centre with chest pain. We will also conduct questionnaires with these patients, to understand their hormone status and how parts of their medical history may be a contributory factor. For patients who have previously attended Barts Heart Centre will will contact them to conduct the questionnaire over the telephone only. We will combine this data with the data that is routinely collected during hospital admission. In this way we hope to understand whether inflammation together with hormone status plays an important role in CAD. Our hope is that through this research we will address an under researched area and find new ways of treating women and men with coronary artery disease.

NCT ID: NCT06326996 Not yet recruiting - Clinical trials for Coronary Heart Disease

Thiamine Intervention and Coronary Artery Bypass Grafting

B1&CABG
Start date: May 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to gain a better understanding of the association between brain changes and cognitive deficits in coronary heart disease (CHD) patients undergoing coronary artery bypass grafting (CABG) and whether a low-cost thiamine intervention can be used to reduce post-CABG cognitive issues in CHD subjects.

NCT ID: NCT06314295 Not yet recruiting - Clinical trials for Coronary Artery Disease

Automated Echocardiographic Detection of Coronary Artery Disease Using Artificial Intelligence Methods

Start date: March 11, 2024
Phase:
Study type: Observational

The incidence rate and mortality of coronary artery disease are increasing year by year. Exploring non-invasive, accurate, and widely applicable methods to screen and diagnosis is of great significance. New ultrasound techniques, such as non-invasive myocardial work, have been proven to be superior to traditional ultrasound techniques in screening and diagnosis. However, diagnostic analysis based on ultrasound video images is time-consuming and subjective. The progress of artificial intelligence technology in fully automated quantitative evaluation of video images provides the possibility for computer-aided design screening and diagnosis. At present, the application of artificial intelligence in computer-aided design is a cutting-edge issue in the field of cardiovascular disease research. The application of artificial intelligence technology in the construction of computer-aided diagnostic models based on ultrasound video images is still in its early stages.

NCT ID: NCT06273293 Not yet recruiting - Coronary Disease Clinical Trials

Postprocedural Contrast Mediated FFR Plus Intracoronary Infusion of Nitroglycerin in Multivessel Patients (PROMETEUS TRIAL)

Start date: March 20, 2024
Phase: N/A
Study type: Interventional

the use of pressure wires is the standar of care to evaluate angiographically intermediate coronary lesions, however, limitations in the management of these type of lesions continue to be a challenge for the interventional cardiologist. The use of FFR has some limitations such as the use of adenosine due to its cost, adverse effects (e.g. transient atrioventricular block, angina, headache, etc.), time consuming and some relative contraindications for its use. In this sense, in recent years new rest indices (iFR, RFR, dPR) and hyperemic indices without adenosine (cFFR-NTG, Pd/Pa-NTG or cFFR) have been developed, demonstrating an improvement in terms of outcomes with its use, so they can also be used as a tool to guide us to plan our strategy. These new indices, particularly the cFFR-NTG, are simpler, at least as safe and have an excellent correlation with the FFR with adenosine in the assessment of intermediate coronary lesions. In recent years, functional assessment after intervention has also been increasingly implemented, which, like intracoronary imaging, can make us change our attitude and correlate with the prognosis. The lower implementation of this practice, especially in multivessel patients, may result from having to lose the position of the wire to check equalization, difficulty in crossing the wire, wear/breakage of the material after diagnosis (2-3 vessels), use more time and contrast, etc. These problems could be reduced, at least partially, with the use of the workhorse coronary guidewire pressure microcatheter to measure post-PCI functional assessment. Although the usefulness of post-PCI FFR has been demonstrated, there is no clearly established cut-off value (0.84-0.96) and it seems that in reality the values are a continuum of risk so that the higher the value, the better the prognosis . Furthermore, other simpler indices such as rest or hyperemic indices without adenosine have not been correlated with FFR in post-PCI. The purpose of this study is to evaluate the correlation between cFFR-NTG and other indices taking FFR as a reference in multivessel patients after undergoing intervention. Establish cut-off points and correlate it with adverse cardiovascular events (MACE) in a 1-year clinical follow-up.

NCT ID: NCT06271590 Not yet recruiting - Clinical trials for Coronary Artery Disease

MagicTouchâ„¢Sirolimus-Coated Balloon for Treatment of Coronary Artery Lesions in Small Vessels

MAGICAL-SV
Start date: April 2024
Phase: N/A
Study type: Interventional

This is a multicenter, randomized, single-blind pivotal study to evaluate the safety and efficacy of the MagicTouchTM Drug coated balloon in treatment of small vessels in patients with coronary artery disease. The objective is to establish the safety and efficacy of the Magic TouchTM Drug coated balloon in treatment of small vessels (≤2.75 mm). A total of 1605 subjects will be enrolled in a maximum of 50 study sites located in North America. Additional sites located in Europe and South America may also participate in the study, with non-US sites contributing a maximum of ~50% of enrollees.