Cardiology randomized controlled trial

BACKGROUND: Chronic heart failure (CHF) poses a significant burden on both patients and their family caregivers (FCs), as it is associated with psychological distress and impaired quality of life (QOL). Acceptance and Commitment Therapy (ACT) supports QOL by focusing on value living and facilitates acceptance of psychological difficulties by cultivating psychological flexibility. A protocol is presented that evaluates the effectiveness of a dyad ACT-based intervention delivered via smartphone on QOL and other related health outcomes compared with CHF education only...

Noteworthy in Cardiothoracic Surgery 2023 summarizes a few of the most high-impact trials and provocative trends in cardiothoracic surgery and transplantation this past year. Transplantation using organs procured from donation after circulatory death (DCD) continues to increase, and the American Society of Transplant Surgeons released recommendations on best practices in 2023. We review a summary of data on the impact of DCD on heart and lung transplantation. There has been increased interest in extracorporeal life support (ECLS), particularly after the COVID-19 pandemic, and we review the results of the highly discussed ECLS-SHOCK trial, which randomized patients in cardiogenic shock with planned revascularization to ECLS vs usual care...

IMPORTANCE: Although the results of A Study to Evaluate the Corvia Medical Inc IASD System II to Reduce Elevated Left Atrial Pressure in Patients with Heart Failure (REDUCE LAP-HF II) trial were neutral overall, atrial shunt therapy demonstrated potential efficacy in responders (no latent pulmonary vascular disease and no cardiac rhythm management device). Post hoc analyses were conducted to evaluate the effect of shunt vs sham stratified by responder status. OBJECTIVE: To evaluate the effect of atrial shunt vs sham control on cardiac structure/function in the overall study and stratified by responder status...

IMPORTANCE: Purinergic receptor P2Y12 (P2Y12) inhibitor monotherapy after a certain period of dual antiplatelet therapy (DAPT) may be an attractive option of maintenance antiplatelet treatment for patients undergoing percutaneous coronary intervention (PCI) who are at both high bleeding and ischemic risk (birisk). OBJECTIVE: To determine if extended P2Y12 inhibitor monotherapy with clopidogrel is superior to ongoing DAPT with aspirin and clopidogrel after 9 to 12 months of DAPT after PCI in birisk patients with acute coronary syndromes (ACS)...

INTRODUCTION: Trials evaluating the role of intravascular imaging in percutaneous coronary intervention (PCI) for complex coronary artery disease have yielded mixed results. This study aimed to compare the outcomes of intravascular imaging specifically intravascular ultrasound (IVUS) with those from conventional coronary angiography in complex PCI. METHODS: Comprehensive electronic search of MEDLINE, EMBASE, and Cochrane databases was performed until March 2023 for randomized clinical trials (RCTs) comparing intravascular imaging with coronary angiography in patients undergoing complex PCI...

Background: In this study, we aim to discuss the long-term clinical outcomes of intravascular ultrasound imaging-guided percutaneous intervention (IVUS-PCI) versus angiography-guided percutaneous coronary intervention (PCI) in complex coronary lesions over a mean period of 2 years. Methods: A systematic search and meta-analysis were conducted to assess the efficacy of using intravascular ultrasound or optical coherence tomography guidance in coronary artery stenting compared to angiography. Results: A total of 11 randomized controlled trials with 6740 patients were included...

BACKGROUND: The reduction in cardiovascular disease (CVD) events with edetate disodium (EDTA) in the Trial to Assess Chelation Therapy (TACT) suggested that chelation of toxic metals might provide novel opportunities to reduce CVD in patients with diabetes. Lead and cadmium are vasculotoxic metals chelated by EDTA. We present baseline characteristics for participants in TACT2, a randomized, double-masked, placebo-controlled trial designed as a replication of the TACT trial limited to patients with diabetes...

Atrial fibrillation (AF) is the most commonly observed arrhythmia in the world and its prevalence increases with age. The main and most severe complication of AF is ischemic stroke. Oral anticoagulation (OAC) therapy is the standard of care for stroke prevention in the high risk population. Initiation of this treatment is associated with a substantial risk of bleeding complications. Moreover, there is a group of patients who cannot tolerate OAC. In patients with AF the left atrial appendage (LAA) is the main source of thrombus formation...

OBJECTIVE: To investigate the effects of computerized wobble board exercise training (CWBET) and core stabilization exercise training (CSET) on balance performance, and exercise capacity in heart failure (HF) patients. DESING: Single-blind randomized controlled prospective study. SETTING: Cardiology department of a local university hospital. PARTICIPANTS: Fifty-one patients with HF with reduced ejection fraction, whose clinical status and medication had been stable for the previous three months, were included...

RATIONALE: Antiplatelet therapy (APT) is the standard of care after endovascular revascularization (EVR) in patients with peripheral artery disease (PAD). APT aims to prevent both major adverse cardiovascular events (MACE) and major adverse limb events (MALE). Nonetheless, the rates of MACE and MALE after EVR remain high. In coronary artery and cerebrovascular disease, dual APT (DAPT)compared to acetylsalicylic acid alone has proven to reduce MACE without increasing the risk of major bleeding when applied for a restricted number of weeks...

BACKGROUND: Concomitant atrial fibrillation and end-stage renal disease is common and associated with an unfavorable prognosis. Although oral anticoagulants have been well established to prevent thromboembolism, the applicability in patients under long-term dialysis remains debatable. The study aimed to determine the efficacy and safety of anticoagulation in the dialysis-dependent population. METHODS AND RESULTS: An updated network meta-analysis based on MEDLINE, EMBASE, and the Cochrane Library was performed...

BACKGROUND: We performed a review of acute stroke trials to determine features associated with premature termination of trial enrollment, defined by the authors as not meeting preplanned sample size. METHODS AND RESULTS: MEDLINE was searched for randomized clinical stroke trials published in 9 major clinical journals between 2013 and 2022. We included randomized clinical trials that were phase 2 or 3 with a preplanned sample size ≥100 and a time-to-treatment within 24 hours of onset for transient ischemic attack, ischemic stroke, or intracerebral hemorrhage...

Survival to hospital discharge among patients with out-of-hospital cardiac arrest (OHCA) is low and important regional differences in treatment practices and survival have been described. Since the 2017 publication of the Canadian Cardiovascular Society's position statement on OHCA care, multiple randomized controlled trials have helped to better define optimal post cardiac arrest care. This working group provides updated guidance on the timing of cardiac catheterization in patients with ST-elevation and without ST-segment elevation, on a revised temperature control strategy targeting normothermia instead of hypothermia, blood pressure, oxygenation, and ventilation parameters, and on the treatment of rhythmic and periodic electroencephalography patterns in patients with a resuscitated OHCA...

BACKGROUND: Sodium-glucose cotransporter 2 inhibitors are believed to improve cardiac outcomes due to their osmotic diuretic potential. OBJECTIVES: The goal of this study was to test the hypothesis that vasopressin-driven urine concentration overrides the osmotic diuretic effect of glucosuria induced by dapagliflozin treatment. METHODS: DAPA-Shuttle1 (Hepato-renal Regulation of Water Conservation in Heart Failure Patients With SGLT-2 Inhibitor Treatment) was a single-center, double-blind, randomized, placebo-controlled trial, in which patients with chronic heart failure NYHA functional classes I/II and reduced ejection fraction were randomly assigned to receive dapagliflozin 10 mg daily or placebo (1:1) for 4 weeks...

OBJECTIVE: This study investigated the effectiveness of individualized nutrition training for mothers of children who underwent congenital heart disease (CHD) surgery on their children's growth and development. METHODS: The researchers conducted a randomized controlled trial at Çukurova University Medical Faculty Balcalı Hospital in Adana, Turkey, between January 20th, 2021, and June 30th, 2021. They recruited 42 children with CHD and their families. Researchers used a personal information form, growth parameter measurements, and the Ankara Developmental Screening Inventory to assess the children...

BACKGROUND: Following percutaneous coronary intervention with stent placement to treat acute coronary syndromes, international clinical guidelines generally recommend dual antiplatelet therapy with aspirin plus a P2Y12 receptor inhibitor for 12 months to prevent myocardial infarction and stent thrombosis. However, data on single antiplatelet therapy with a potent P2Y12 inhibitor earlier than 12 months after percutaneous coronary intervention for patients with an acute coronary syndrome are scarce...

INTRODUCTION: The use of angiotensin II receptor blockers (ARBs) in the treatment of hypertrophic cardiomyopathy (HCM) remains a subject of controversy. METHODS: We conducted a comprehensive search of the Cochrane Library, PubMed, EMBASE, ClinicalTrials.gov, and Web of Science databases until October 2023 to identify articles investigating the effects of ARBs in patients diagnosed with HCM. Predefined criteria were utilized for selecting data on study characteristics and results...

BACKGROUND AND AIMS: Older patients with non-ST-elevation acute coronary syndrome (NSTEACS) are less likely to receive guideline-recommended care including coronary angiography and revascularization. Evidence-based recommendations regarding interventional management strategies in this patient cohort are scarce. This meta-analysis aimed to assess the impact of routine invasive vs. conservative management of NSTEACS by using individual patient data (IPD) from all available randomized controlled trials (RCTs) including older patients...

(1) Background: Cardiac rehabilitation often emphasizes aerobic capacity while overlooking the importance of muscle strength. This study evaluated the impact of an enhanced remote strength training program (RCR-ST) on cardiac rehabilitation. (2) Methods: In this randomized prospective study (RCT registration number SMC-9080-22), 50 patients starting cardiac rehabilitation were assessed for muscle strength, aerobic capacity, and self-reported outcomes at baseline and after 16 weeks. Participants were divided into two groups: the RCR-ST group received a targeted resistance training program via a mobile app and smartwatch, while the control group received standard care with general resistance training advice...

BACKGROUND: The AEGIS-II trial hypothesized that CSL112, an intravenous formulation of human apoA-I, would lower the risk of plaque disruption, decreasing the risk of recurrent events such as myocardial infarction (MI) among high-risk patients with MI. OBJECTIVES: This exploratory analysis evaluates the effect of CSL112 therapy on the incidence of CV death and recurrent MI. METHODS: The AEGIS-II trial was an international, multicenter, randomized, double-blind, placebo-controlled trial that randomized 18,219 high-risk acute MI patients to 4 weekly infusions of apoA-I (6g CSL112) or placebo...