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Heart Diseases clinical trials

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NCT ID: NCT04138745 Completed - Clinical trials for Congenital Heart Disease

Transverse Thoracic Plane Block in the Pediatric Cardiac Patient

TTPPCT
Start date: January 1, 2018
Phase:
Study type: Observational

Postoperative pain after cardiothoracic surgery can be a significant problem interfering with recovery, yet difficult to manage due to the sedating effects of opiates. These patients frequently have associated postoperative pulmonary changes and are at risk of respiratory depression with opioid analgesia. The ultrasound-guided transversus thoracic muscle plane block (TTMPB) is a recently described regional anesthetic technique showing improvements in postoperative pain management. Further investigation is needed to establish the potential of the TTMPB as an analgesic modality in congenital cardiothoracic surgery in patients under the age of 18.

NCT ID: NCT04136379 Completed - Clinical trials for Congenital Heart Disease

Comparison of Home and Standard Clinic Monitoring of INR in Patients With CHD

Start date: September 30, 2019
Phase:
Study type: Observational

Summary: Congenital heart disease (CHD) is the most prevalent form of birth defect with a global rate of 1.35 million newborns born with CHD annually. Patients with CHD have an increased risk of cerebrovascular accident (CVA) compared to age-matched control populations. Anticoagulation with warfarin is the mainstay of antithrombotic treatment in these patients and requires frequent monitoring of the International Normalized Ratio (INR). The CoaguChek monitor is a point of care device that enables patients to self-monitor and manage their INR without the need to attend a warfarin clinic. The aim of this study is to compare the efficacy and outcomes of standard clinic management and home management of INR in patients with CHD. Analysis of time in therapeutic range (TTR), INR variability, major and minor bleeding events, incidence of CVA and other thrombotic events will be undertaken. Original Hypothesis: There will be a difference in the proportion of time that patients spend in their therapeutic range and the amount of adverse events that occur between those who use a CoaguChek monitor and those who use standard clinic monitoring of their INR. The primary outcome will be time in therapeutic range (TTR). Secondary outcomes will be INR variability, minor / major bleeding complications and thromboembolic events.

NCT ID: NCT04135859 Completed - Physical Activity Clinical Trials

Young Adult Congenital Heart Disease Physical Activity Lifestyle Study (YACHD-PALS)

YACHD-PALS
Start date: March 14, 2019
Phase: N/A
Study type: Interventional

This study will adapt a physical activity lifestyle intervention to emerging adult congenital heart disease (CHD) survivors with the primary goal of increasing physical activity levels. The study will be split into 2 phases. In Phase 1, participants will be asked to complete questionnaires, wear an accelerometer around the waist for 7 days, and undergo an exercise stress test. The accelerometer and exercise stress test will be used to determine whether participants are eligible to be randomized for the intervention study. In Phase 2, participants will be randomized to one of two conditions: 1) receiving a physical activity tracker (a Fitbit) or 2) receiving a Fitbit AND engaging in videoconferencing sessions with a physical activity coach. During Phase 2, participants will also be asked to complete 3 assessments (weeks 9 and 22, and a 6-month follow-up). The week 9 assessment will consist of completing questionnaires and wearing an accelerometer for 7 days. Week 22 will be similar to week 9 with the addition of a final exercise stress test. The 6-month follow-up will mirror the week 9 assessment. Participants who are randomized to the videoconferencing condition will be asked to meet with a physical activity coach 8 times over the course of 20 weeks. Coaches will help participants to (1) change attitudes toward physical activity, (2) increase perception of others' approval of physical activity (e.g., family members, peers), and (3) increase participants' perceived control by troubleshooting barriers and increasing efficacy for physical activity. Coaches will use the Fitbit to facilitate self-monitoring and goal setting. Participants in the intervention arm will be asked to participate in a focus group at the conclusion of the study to share their experiences.

NCT ID: NCT04131725 Completed - Cardiac Disease Clinical Trials

Cardiac Function Non-Invasive Monitoring System Evaluation Trial

Start date: November 9, 2020
Phase:
Study type: Observational

Non-significant risk device study to conduct evaluation of the performance of new device for monitoring of cardiac function (based on previous iterations 510(k) 173156)

NCT ID: NCT04131075 Recruiting - Depression Clinical Trials

The Cerebral-Coronary Connection (C3) Study

C3
Start date: March 1, 2017
Phase:
Study type: Observational

This is a prospective cohort blinded study with the aim to investigate the prevalence and clinical impact of coronary microcirculatory dysfunction (CMD) in patients with ischemic heart disease, and its association with cerebral small vessel disease (CSVD) and depressive disorders. In addition, CMD and CSVD linkage to systemic inflammation and endothelial function will also be investigated.

NCT ID: NCT04130243 Active, not recruiting - Clinical trials for Pulmonary Arterial Hypertension

Biomarkers in Pediatric Congenital Heart Disease and PAH

Start date: December 5, 2017
Phase:
Study type: Observational [Patient Registry]

Nowadays, biomarkers are broadly used in clinical practice. Blood-derived biomarkers fulfil an important role in the field of cardiology. However, most biomarkers have been investigated for adult left ventricular disease. In congenital heart diseases (CHD) and pulmonary arterial hypertension (PAH), which involves children and mostly the right ventricle, less is known about the clinical and predictive value of blood-derived biomarkers. Since the group of survivors of CHD and PAH is growing because of the improved techniques nowadays, development of better tools to maintain the quality of life for the longer term in these patients is urgently needed. Blood-derived biomarkers are minimally invasive biomarkers, are quantitative and have shown to be able to reveal pathological processes in an early stage. Hence, blood-derived biomarkers may be a good addition to current diagnostic means in CHD and PAH. Objective: The primary objective of this study is to investigate cross-sectionally the association between various emerging blood-derived biomarkers and right ventricular (RV) function:defined as tricuspid annular plane systolic excursion (TAPSE) measured with echocardiography, in children with (a history of ) an abnormally loaded, volume and/or pressure loaded, right ventricle associated with CHD and/or PAH.

NCT ID: NCT04128475 Terminated - Clinical trials for Cardiovascular Diseases

Observational Study of Cardiovascular Disease.

FOURIER LEGACY
Start date: February 5, 2020
Phase:
Study type: Observational

This observational study will follow participants who completed follow-up in the FOURIER OUTCOMES trial to evaluate the long-term effects of evolocumab treatment. Long-term post-trial (legacy) beneficial effects have been reported with statins, niacin, hypoglycemic therapy and fibrates. Whether similar effects are seen after LDL cholesterol (LDL-c) lowering by PCSK9 inhibition is currently unknown. Evolocumab therapy causes a profound reduction in LDL cholesterol of approximately 60%. Statins have shown legacy effects over 5 years post-trial, including a 7% reduction in total mortality in meta-analysis and 12% reduction in coronary mortality. It would therefore be hypothesized that additional effects beyond the trial period would be conferred by previous evolocumab treatment. It is also important to assess the long-term safety of prior evolocumab treatment.

NCT ID: NCT04127474 Recruiting - Clinical trials for Coronary Heart Disease

Expression of Trefoil Factors and Adrenomedullin in Subjects With Chronic Periodontitis and Coronary Heart Disease

Start date: October 14, 2019
Phase:
Study type: Observational

To assess the demographic variables, periodontal parameters and to determine the expression of Trefoil factors 2 and 3 and Adrenomedullin in unstimulated saliva samples of periodontally healthy subjects with coronary heart disease and generalised chronic periodontitis subjects with and without coronary heart disease.

NCT ID: NCT04126018 Recruiting - Aortic Stenosis Clinical Trials

Comparative Imaging Assessment of Valvular Heart Disease

Start date: August 23, 2019
Phase:
Study type: Observational

The purpose of the study is to compare the various 2D and 3D methods of valvular heart disease quantification (Doppler, PISA, VCA, volumetric method) and strain with cardiac magnetic resonance (CMR) measurements of left and right ventricular systolic function strain and myocardial fibrosis assessment.

NCT ID: NCT04125732 Completed - Clinical trials for Coronary Artery Disease

Epicardial Delivery of XC001 Gene Therapy for Refractory Angina Coronary Treatment (The EXACT Trial)

EXACT
Start date: January 24, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

The primary purpose of this trial is to determine the safety of XC001 (AdVEGFXC1) in patients who suffer from angina caused by coronary artery disease and have no other treatment options. Subjects in this study will receive one of four intramyocardial doses of XC001 that expresses human vascular endothelial growth factor (VEGF) which induces therapeutic angiogenesis (revascularization).