MCG Discovery Study in Emergency Departments
ACS - Acute Coronary SyndromeNSTEMI - Non-ST Segment Elevation MIThis prospective discovery study is designed to demonstrate the feasibility of using an unshielded, mobile MCG device in an Emergency Department (ED) setting. The main question it aims to answer is whether interpretable data can be reliably collected as part of an ED workflow.
The SleepWell Study - Chronotherapeutic Intervention to Improve Sleep Following ACS
Sleep DisturbanceInsomnia1 moreThis two-phase pilot study will test the feasibility of a "combined chronotherapy" (CC) intervention consisting of morning bright light therapy (BLT) and evening blue light blocking (BLB), administered daily for 4 weeks in patients who experienced acute coronary syndrome (ACS). Phase A of the study will be a single-arm open-label study of the home-based CC intervention in 5 post-ACS patients. Phase B of the study will be a parallel-arm randomized clinical trial (RCT) in which 15 post-ACS patients will be randomized (using a 2:1 allocation) to active CC treatment or sleep hygiene education control group. In Phase A and Phase B, the primary aims are study feasibility, acceptability, appropriateness, and usability. In Phase B, the investigator will additionally assess whether the intervention engages its proposed proximal target mechanism - sleep.
Telehealth-enhanced Hybrid Cardiac Rehabilitation Among Acute Coronary Syndrome Survivors
Acute Coronary SyndromeMyocardial InfarctionThis study investigates the feasibility of conducting a randomized controlled trial of telehealth-enhanced hybrid cardiac rehabilitation (THCR) compared with traditional cardiac rehabilitation (CR) among acute coronary syndrome (ACS) survivors. THCR is a novel, hybrid model that targets the same core components as traditional CR (e.g., exercise training, patient education, and risk factor management), but uses a mixture of telehealth, clinic-, and home-based activities to offer 24 CR sessions (5 clinic-based + 19 home-based) over 12 weeks.
OptimiZation Of Lipid Lowering Therapies Using a Decision Support System In Patients With Acute...
Acute Coronary SyndromeMyocardial Infarction1 moreThe goal of this clinical trial is to compare implementation of a Decision Support System (DSS) - aligned to the 2019 ESC/EAS Guidelines - in addition to routine clinical care versus routine clinical care without availability of a DSS, in participants aged ≥18 to < 80 years old presenting with Acute Coronary Syndrome (ACS). The main questions it aims to answer are: to assess whether the availability of a DSS (which provides estimates of risk and estimates of potential benefit through LDL-C lowering) to current practice results in an increase in the early initiation of combination Lipid Lowering Therapies (LLTs) or intensification of LLT regimens compared to current practice alone over a 24-week period after an Acute Coronary Syndromes (ACS) event To estimate in the study cohort the potential benefits of guideline-based LLT intensification via simulation-based methods using estimates of baseline risk: LLT utilisation, additional LDL-C reductions and LDL-C goal achievement, on simulated risk of CV events through modelling. Participants will give consent to randomised clinical sites to collect their data. The clinical sites will either be randomised to standard of care or the availability of and access to the DSS. Researchers will compare patients from DSS and Non-DSS sites to see if the availability of the DSS results in implementation of more intensive lipid lowering regimens, resulting in the achievement of lower LDL-C values as well as the proportion of patients who reach target LDL-C levels (<1.4 mmol/L (<55 mg/dL) by Week 24.
Post Acute Cardiac Event Smoking (PACES) Study
Acute Coronary SyndromeTobacco UseSummary of the Project : Quitting smoking following acute coronary syndrome (ACS) can reduce mortality up to 50%. However, depression and smoking are highly co-morbid and depressed mood may interfere with cessation and independently predicts mortality. Thus, a single, integrated treatment for both smoking and depression could be highly effective in reducing post-acute coronary syndrome mortality. Behavioral Activation (BA) is a well established treatment for depression and has recently shown promise as a treatment for smoking cessation. The investigators systematically developed an intervention integrating gold standard smoking cessation counseling with existing BA based mood management techniques for post-ACS smokers; Behavioral Activation Treatment for Cardiac Smokers (BAT-CS). Objective: For this R01 the investigators will evaluate the efficacy of using a single, integrated treatment that targets both depressed mood and smoking (BAT-CS).
Safety and Efficacy of Drug-Coated Balloon for De-novo Lesions in Patients With Acute Coronary Syndromes...
Drug-Coated BalloonDe Novo Stenosis5 moreThe DCB-ACS trial is a prospective, multi-center, non-inferiority, randomized controlled trail. The purpose of this trial is to evaluate the safety and efficacy of drug-coated balloon(DCB) in de novo lesions for acute coronary syndromes (ACS) .
Evolocumab in Patients With Acute MI
Acute Coronary SyndromeVascular and myocardial inflammation are significantly increased in Acute Coronary Syndrome (ACS) patients, are closely correlated to LDL-C levels, and are associated with these adverse consequences in the post-ACS patient population. Serum proprotein convertase subtilisin/kerin type 9 (PCSK9) levels are also increased in ACS, may raise LDL-C, and the investigators' pre-clinical studies indicate that PCSK9 is also a potent inducer of vascular inflammation. The addition of the PCSK9 antibody evolocumab, currently approved to lower LDL-C in certain patient populations, to current medical therapies would appear to be of particular benefit in patients with an ACS by markedly reducing LDL-C, stabilizing vulnerable plaque, and limiting inflammation-associated myocardial cell loss and resultant dysfunction.
Aspirin Twice a Day in Patients With Diabetes and Acute Coronary Syndrome
Diabetes MellitusAcute Coronary Syndrome2 moreTo compare treatment with Aspirin Protect® twice a day (100 mg in the morning and 100 mg in the evening) versus Aspirin Protect® 100 mg once per day on a composite end-point of ischemic events in diabetic patients, or in patients with a known risk factor for non-optimal aspirin response (obesity, abdominal obesity or coronary event occurring with long-term aspirin),with acute coronary syndrome. It is expected that aspirin taken twice a day will reduce the occurrence of new ischemic event after acute coronary syndrome in diabetic patients or in patients with a known risk factor.
PK/PD Study of Vicagrel and Clopidogrel in Healthy Subjects With Different CYP2C19 Metabolizers...
Acute Coronary SyndromeThis clinical study will adopt an open-label, randomized, multiple-dose, two-crossover design to explore the pharmacokinetic and pharmacodynamic profiles of Vicagrel Capsules and Clopidogrel Tablets in Healthy Subjects with Different CYP2C19 Metabolizers
Evolocumab in Acute Coronary Syndrome
Acute Coronary SyndromeVascular and myocardial inflammation are significantly increased in Acute Coronary Syndrome (ACS) patients, are closely correlated to LDL-C levels, and are associated with these adverse consequences in the post-ACS patient population. Serum proprotein convertase subtilisin/kerin type 9 (PCSK9) levels are also increased in ACS, may raise LDL-C, and the investigators' pre-clinical studies indicate that PCSK9 is also a potent inducer of vascular inflammation. The addition of the PCSK9 antibody evolocumab, currently approved to lower LDL-C in certain patient populations, to current medical therapies would appear to be of particular benefit in an important subset of ACS patients, those with non-ST elevation myocardial infarction (NSTEMI) by markedly reducing LDL-C, stabilizing vulnerable plaque, and limiting inflammation-associated myocardial cell loss and resultant dysfunction.