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Acute Coronary Syndrome clinical trials

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NCT ID: NCT05198492 Active, not recruiting - Atrial Fibrillation Clinical Trials

Short- and Long-term Health Effects of Air Pollution in Poland

EP-PARTICLES
Start date: January 1, 2011
Phase:
Study type: Observational

The effects of air pollution on the frequency of hospital admissions and mortality due to acute coronary syndromes, atrial fibrillation, and renal disfunction are noted also in areas perceived as pollution-free (due to the lack of large industry). The aim of the project is to assess the impact of air pollution in Eastern Poland on regional public health.

NCT ID: NCT04971356 Active, not recruiting - Clinical trials for Acute Coronary Syndrome

1-month DAPT Plus 5-month Ticagrelor Monotherapy Versus 12-month DAPT in Patients With Drug-coated Balloon

CAGEFREEII
Start date: November 1, 2021
Phase: N/A
Study type: Interventional

Drug-Coated Balloon (DCB) angioplasty is similar to plain old balloon angioplasty procedurally, but there is an anti-proliferative medication paclitaxel coated to the balloon. Treating ISR lesions with the DCB has the theoretical advantage of avoiding multiple stent layers and respecting the vessel anatomy. DCB has shown promising results for the treatment of ISR. Currently, DCB has a Class I indication to treat ISR recommended by European Society of Cardiology guidelines. In addition, some interventional cardiologist has also applied DCB in de novo lesions in their clinical practice. Bleeding after PCI remains a substantial clinical problem. Bleeding post-PCI increases the risk of adverse outcomes such as death, non-fatal myocardial infarction, and prolongs hospital stay. Clinical data has suggested that major bleeding post-PCI would increase the risk of mortality 5.7-fold. The antiplatelet medications are the major cause of bleeding events post-PCI. Current guidelines for stents recommended DAPT of aspirin plus a P2Y12 inhibitor for at least 12 months after stent implantation in patients with the acute coronary syndrome. Compared with the DES, because of the absence of metal inside the coronary artery, the use of DCB might theoretically allow shorter duration antiplatelet therapy. However, the optimal course of DAPT for the DCB treated patients remains controversial. In 2013, the consensus from the German group suggested that for the acute coronary syndrome, DAPT should be used for 12 months. The consensus of DAPT developed by the European Society of Cardiology (ESC) in 2017 stated that "in patients treated with DCB, dedicated clinical trials investigating the optimal duration of DAPT are lacking." So far, there are no randomized data showing the optimal DAPT duration for the DCB treated patients. In the current study, we use Aspirin + Ticagrelor for 1-month followed by Ticagrelor monotherapy for 5-month, afterward, Aspirin monotherapy for 6 months to be the antiplatelet regimen in the experimental arm, to compare with the Reference arm, which is Aspirin + Ticagrelor for 12-month in a non-inferiority statistical assumption, aiming to investigate the optimal duration of the DAPT in ACS patients after DCB treatment.

NCT ID: NCT04937803 Active, not recruiting - Clinical trials for Coronary Artery Disease

Safety and Efficacy of Drug-Coated Balloon for De-novo Lesions in Patients With Acute Coronary Syndromes (DCB-ACS)

DCB-ACS
Start date: April 19, 2021
Phase: N/A
Study type: Interventional

The 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) .

NCT ID: NCT04873934 Active, not recruiting - Clinical trials for Acute Coronary Syndrome

Management of LDL-cholesterol With Inclisiran + Usual Care Compared to Usual Care Alone in Participants With a Recent Acute Coronary Syndrome

V-INCEPTION
Start date: June 24, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to study the effectiveness of implementation of a systematic LDL-C management pathway including treatment with inclisiran in participants who have experienced a recent acute coronary syndrome (ACS) and have an increased LDL-cholesterol (≥70 mg/dL) despite being treated with a statin drug,

NCT ID: NCT04799899 Active, not recruiting - Depression Clinical Trials

MBCT Via Group Videoconferencing for Acute Coronary Syndrome Patients With Depressive Symptoms: A Pilot RCT

Start date: April 22, 2021
Phase: N/A
Study type: Interventional

The aim of this study is to establish, in a pilot RCT (approx. N=50 participants) with a time- and attention-matched health enhancement control, (a) the feasibility of the recruitment procedures (screening, eligibility, enrollment rates), and feasibility and acceptability of the (b) MBCT and control interventions (adherence, retention, fidelity, satisfaction, group videoconferencing delivery) and (c) data collection procedures by group (adherence, satisfaction). Hypothesis 1a: Recruitment will be feasible as evidenced by screening, eligibility, and enrollment rates; (1b) the MBCT and control interventions and (1c) data collection procedures in both groups will be feasible and acceptable.

NCT ID: NCT04794868 Active, not recruiting - Clinical trials for Acute Coronary Syndrome

PreDiction and Validation of Clinical CoursE of Coronary Artery DiSease With CT-Derived Non-Invasive HemodYnamic Phenotyping and Plaque Characterization (DESTINY Study)

DESTINY
Start date: April 1, 2020
Phase:
Study type: Observational [Patient Registry]

Acute coronary syndrome (ACS) and sudden cardiac death can be the first manifestation of coronary artery disease and are the leading cause of death in the majority of the world's population. The main pathophysiology of ACS is well-known and fibrous cap thickness, presence of a lipid core, and the degree of inflammation have been proposed as the key determinants of plaque vulnerability. Previous studies using virtual histology intravascular ultrasound or optical coherence tomography showed that clinical application of this concept improved risk prediction of ACS. However, these approaches have not been widely adopted in daily practice due to relatively low positive predictive values, low prevalence of high-risk plaques and the invasive nature of diagnostic modalities. Non-invasive imaging studies with coronary computed tomography angiography (CCTA) also showed the clinical value of CCTA-derived high risk plaque characteristics (HRPC). In addition, the recent progress in CCTA and computational fluid dynamics (CFD) technologies enables simultaneous assessment of anatomical lesion severity, presence of HRPC and quantification of hemodynamic forces acting on plaques in patient-specific geometric models. As plaque rupture is a complicated biomechanical process influenced by the structure and constituents of the plaque as well as the external mechanical and hemodynamic forces acting on the plaque, a comprehensive evaluation of lesion geometry, plaque characteristics and hemodynamic parameters may enhance the identification of high-risk plaque and the prediction of ACS risk. In this regard, the current study is designed to evaluate prognostic implications of comprehensive non-invasive hemodynamic assessment using CCTA and CFD in the identification of high risk plaques that caused subsequent ACS.

NCT ID: NCT04772157 Active, not recruiting - Clinical trials for Acute Coronary Syndrome

Safe Emergency Department dIscharGE Rate (SEIGE)

SEIGE
Start date: October 13, 2020
Phase:
Study type: Observational

The Siemens POC High Sensitivity Troponin-I Test System is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I (cTn-I) in fresh human capillary (fingerstick) whole blood, and lithium-heparinized venous whole blood or plasma, to be used by healthcare professionals at the point of care (POC) as well as in the clinical laboratory. The Siemens POC High Sensitivity Troponin-I Test System is to be used as an aid in the diagnosis of myocardial infarction (MI).

NCT ID: NCT04739098 Active, not recruiting - Clinical trials for Acute Heart Failure, Non-ST-segment Elevation Acute Coronary Syndrome

Initial Manifestations of Congestive Heart Failure in Patients With NSTEACS

Start date: January 30, 2020
Phase:
Study type: Observational

Acute heart failure (HF) is a common complication of acute coronary syndrome (ACS) associated with poor prognosis. Diagnosis of congestive HF in patients with initial, non-severe symptoms and signs may be challenging and early stages of this complication may be missed. To assess severity of HF in patients with ACS Killip classification is widely used but it does not take into account mild manifestations of HF. Thus, patients without rales in the lungs and/or S3 will be labelled as Killip class 1. The aim of this study is to determine the frequency, risk factors, abilities for early diagnosis using routine medical evaluation and clinical significance of subclinical and mildly symptomatic congestive HF in patients with ACS without persistent ST-segment elevation (NSTEACS). The study will include 200 patients with NSTEACS without history of severe HF and overt signs of congestion at presentation. Presence and severity of dyspnea (according to Likert ans Visual analog scales), physical signs of heart failure (respiratory rate, distention of jugular veins, S3), peripheral oxygen saturation by pulse oximetry, heart rate and signs of ischemia on ECG, signs of congestion according to lung and vena cava inferior ultrasound and chest X-Ray/CT as well as levels of NT-proBNP, hsTn, CRP and FABP at presentation will be evaluated. Presence and severity of dyspnea, physical signs of heart failure, oxygen saturation, heart rate and signs of ischemia on ECG, lung and vena cava inferior ultrasound will be re-assessed after 6, 12 and 24 hours. During hospitalization occurrence or worsening of clinical HF. Clinical events will be followed up to 12 months after hospitalization.

NCT ID: NCT04630288 Active, not recruiting - Clinical trials for Acute Coronary Syndromes

Safety and Efficacy of Ticagrelor vs Clopidogrel in Patients With Acute Coronary Syndrome

Start date: July 2, 2019
Phase:
Study type: Observational

Multicenter post-approval observational retrospective cohort study in routine clinical practice (Real World Evidence Study) to assess the 1-year safety profile associated with ticagrelor and clopidogrel therapy in a contemporary reprospective cohort of patients who survived the initial 30-day period after the index hospitalization for acute coronary syndrome (ACS).

NCT ID: NCT04624854 Active, not recruiting - Clinical trials for Coronary Artery Disease

Dual Anti-Platelet Therapy in Patients With Coronary Multi-Vessel Disease (DAPT-MVD)

Start date: October 27, 2020
Phase: Phase 4
Study type: Interventional

This study is a prospective, multicenter, parallel, open-label, randomized, controlled, superiority trial. It is planned to recruit 8,250 patients with multi-vessel disease(MVD), and the patients will be followed-up for at least 12 months after being implanted with a drug-eluting stent (DES) at one of 100 different centers. All patients will be randomly divided into the treatment group and control group on a 1:1 basis, based on a complete randomization.