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Coronary Artery Disease clinical trials

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NCT ID: NCT05548023 Active, not recruiting - Clinical trials for Cardiovascular Diseases

Time-trend Analysis of Clinical Characteristic and Outcomes in Patients With Unprotected Left Main Coronary Artery Disease Treated With PCI Over a 10-year Period

Start date: December 8, 2023
Phase: N/A
Study type: Interventional

Surgical coronary bypass surgery (CABG) has been demonstrated to confer significant survival benefit over medical therapies patients with LMCA in earlier clinical trials1,2,3 and therefore was the revascularization modality of choice for a long time. Recently, several randomized controlled trials and meta-analyses have shown percutaneous coronary intervention (PCI) to be non-inferior to CABG in the treatment of LMCA disease4,5,6,7,8. PCI is now considered to be an appropriate alternative to CABG for LMCA disease in patients with suitable anatomy9,10. Over recent decades, LMCA PCI has been performed in patients with increasing anatomical complexity and higher risk profiles (e.g. elderly, heart failure, renal failure etc). 11,12. In recent years, remarkable advancement in interventional techniques and technologies such as 2nd/3rd generation DES and potent antiplatelet therapy have contributed to the improvement of PCI success rates and reduction in complications and adverse events. Knowledge related to long term temporal variation of clinical and procedural characteristics and outcomes in patients with LMCA disease treated with PCI will therefore be important to inform and define future treatment strategies. This proposal aims to evaluate time-trends and regional differences in clinical characteristics and outcomes of patients with LMCA disease treated with PCI in the Asia-Pacific region

NCT ID: NCT05515666 Active, not recruiting - Clinical trials for Coronary Artery Disease

The Value of Wearable Electrocardiogram in the Diagnosis of Coronary Artery Disease

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

ECG is one of the classic tests for coronary artery disease, but patients with coronary artery disease often have no onset of typical symptoms at the time of consultation, so it is difficult to capture ischemic changes on a conventional ECG. In this study, a diagnostic test was performed to assess the diagnostic value of wearable ECG for coronary artery disease, with the gold standard of coronary angiography and quantitative flow fraction. In addition, we followed up with the enrolled participants for 1 year to assess the relationship between wearable ECG and long-term prognosis.

NCT ID: NCT05514652 Active, not recruiting - Clinical trials for Coronary Artery Disease

Anesthesia Standard Operating Procedure During On-pump Coronary Artery Bypass Grafting

Start date: December 1, 2018
Phase: N/A
Study type: Interventional

Background: Despite improvements in surgical and anesthesia procedures over the past 15 years complications during cardiac surgery still remain high. Bridgewater B et al. describes mortality during on-pump coronary artery bypass grafting (CABG) at 2%-3%, and the rate postoperative complications about 20%-30%. At the same time, the standard of care in patients undergoingon-pump CABG is not fully established. Hypothesis, Research Need: Use of multimodal low-dose opioid anesthesia during CABG decreases inflammatory response and the incidence of early postoperative cardiac complications due to a reduction in interleukin-6. Methodology: According to anesthesia standard protocol, all patients were divided into two groups - study group with multimodal low-dose opioid anesthesia (60 patients) and control group with a high-dose opioid anesthesia (60 patients). Primary (IL-6 at the end of the operation) and secondary clinical outcomes (postoperative atrial fibrillation (POAF), low cardiac output syndrome (LCOS), duration of mechanical ventilation (MV), length of intensive care unit (ICU) stay, length of hospital stay) were compared between the groups. Analysis Tools: Clinical observations; instrumental research methods (electrocapdiography, echocardiography); labs (blood gases, hemoglobin, electrolytes); enzyme-linked immunosorbent assay (IL-6); statistical (Student's t-test, Mann-Whitney U test, χ2-test, correlation analysis). Expected Outcomes: Use of multimodal low-dose opioid anesthesia during CABG will decrease inflammatory response (lower levels of IL-6 at the end of the surgery) and the incidence of early postoperative cardiac complications, expressed as lower incidence of LCOS and POAF, lower duration of MV and lower length of ICU stay.

NCT ID: NCT05500443 Active, not recruiting - Clinical trials for Coronary Artery Disease

The DANish COronary DEcalcification (DANCODE) Trial

DANCODE
Start date: February 8, 2023
Phase: N/A
Study type: Interventional

1. Abstract Introduction Coronary artery calcification (CAC) and especially progression in CAC is a strong predictor of acute myocardial infarction and cardiovascular mortality. A substudy in the recent Danish study, AVADEC, suggested a protective role of supplementation with vitamin K2 and D in the development of CAC. This finding should be interpreted with caution, but the perspective is very interesting. In this study, we will examine the effect of the supplementation on progression of CAC in men and women with severe CAC. We hypothesize that the supplementation will slow down the calcification process. Method and analysis In this multicenter and double-blinded placebo-controlled study, 400 men and women with CAC score ≥ 400 are randomized (1:1) to treatment with vitamin K2 (720 µg/day) and vitamin D (25 µg/day) or placebo treatment (no active treatment) for two years. Exclusion criteria are treatment with vitamin K antagonist or coagulation disorders. To evaluate CAC score, a non-contrast CT-scan is performed at baseline and repeated after 12 and 24 months of follow-up. Primary outcome is difference in CAC score from baseline to follow-up at two years. Intention-to-treat principle is used for all analyses. Ethics and dissemination There are no reported adverse effects associated with the use of vitamin K2. Prior to inclusion, the protocol will be approved by the Regional Scientific Ethical Committee for Southern Denmark and the Data Protection Agency. It will be conducted in accordance with the Declaration of Helsinki. Positive as well as negative findings will be reported.

NCT ID: NCT05464147 Active, not recruiting - Clinical trials for Coronary Artery Disease

DYNAMX Bioadaptor ImplanTation for the trEatment of Complex Coronary Lesions

DYNAMITE
Start date: October 19, 2021
Phase: N/A
Study type: Interventional

The aim of the DYNAMITE study is to investigate the (a) acute procedural and (b) 9-month follow-up performance of DynamX Drug-Eluting Coronary Bioadaptor System implantation in complex coronary lesions.

NCT ID: NCT05461729 Active, not recruiting - Clinical trials for Coronary Artery Disease

TIMELY Prospective Study

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

Brief Summary: Cardiac rehabilitation (CR) is a multi-factorial intervention, designed to limit the physiological and psychological effects of cardiovascular disease such as coronary artery disease (CAD), manage symptoms, and reduce the risk of future cardiovascular events. CR is a structured program not only addressing CAD but also comorbidities including hypertension, dyslipidemia, diabetes and obesity as well as other risk factors. CR aims at long-term lifestyle changes to reduce modifiable risk factors, and it's success depends on a large number of interacting variables including biological, psychological and social factors. Recently, the importance of patient-centered approaches to secondary prevention and CR success has been underlined but intra-individual factors and their interactions are not well understood. The TIMELY prospective study aims to collect high-resolution data for data mining and artificial intelligence machine learning models to identify dependencies between factors and predict favorable outcomes of CR. Data collection will include data documented during controlled center-based CR as well as remote-measurement of physical activity data, (central) blood pressure and pulse wave analysis as well as long-term ECG data during a 6-months period after discharge. Follow-up assessments will be performed at least at 6 months and at 12 months after discharge. Main objectives of the study: 1. To examine uptake and adherence to a healthy lifestyle (i. e. adherence to CR guidelines in CAD) and the effects on long-term outcomes. 2. To identify potentially mediating mechanisms and predictive factors for long-term CR success in CAD. 3. To investigate acceptance of different eHealth components as well as expectations and needs among CAD patents in CR.

NCT ID: NCT05453097 Active, not recruiting - Cardiac Arrhythmia Clinical Trials

Prognostic Value of the Selvester QRS Score for Perioperative Myocardial Injury Following Non-cardiac Surgery

Start date: August 11, 2022
Phase:
Study type: Observational

The purpose of this study to determine the prognostic value of the Selvester QRS score for perioperative myocardial injury following elective non-cardiac surgery.

NCT ID: NCT05433376 Active, not recruiting - Clinical trials for Coronary Artery Disease

SOLSTICE Trial in China

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

This is a small sample size clinical trial in Chinese population to assess the safety and effectiveness of the Shockwave Coronary Intravascular Lithotripsy (IVL) System to treat de novo, calcified, stenotic, coronary lesions prior to stenting.

NCT ID: NCT05424705 Active, not recruiting - Clinical trials for Coronary Artery Disease

Prediction of Atherosclerotic Plaque Progression

PPP
Start date: January 15, 2015
Phase:
Study type: Observational

To predict coronary atherosclerosis progression in patients with acute coronary syndrome by the use of intracoronary imaging methods. To investigate the ability of NIRS to detect vulnerable plaque characterized by the presence of OCT-defined TCFA To study the influence of gene polymorphisms (in genes playing role in vessel dilatation) on the progression of coronary atherosclerosis and clinical outcomes

NCT ID: NCT05423379 Active, not recruiting - Clinical trials for Coronary Artery Disease

XIENCE Skypoint Large Vessel Post Approval Study

SPIRIT XLV PAS
Start date: September 14, 2022
Phase:
Study type: Observational

SPIRIT XLV PAS is a prospective, single arm, multi-center, US and OUS post-approval observational study to evaluate the continued safety and effectiveness of the XIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent System (EECSS) Large Vessel (LV) sizes (diameter 4.5 mm and 5.0 mm) during commercial use in a real-world setting.