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Cardiovascular Diseases clinical trials

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NCT ID: NCT03771573 Recruiting - Clinical trials for Cardiovascular Diseases

Rehabilitation With Exercises in Cardiovascular Diseases

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

INTRODUCTION: Cardiovascular diseases are the main causes of death in Brazil and in the world, associated with a large number of people with physical disabilities and disability, significantly burdening public health expenditures. Some patients end up having the need to do cardiac surgeries. , and consequently suffer complications associated with the surgical process due to prolonged rest in the bed, and complications are directly related to the morbidity and mortality rate in these patients. Thus, cardiac rehabilitation has great scientific evidences that directly impacts functional capacity, quality of life and thus reducing the morbimortality rate of these patients. However, it is worth noting that there is no outpatient cardiovascular rehabilitation service linked to the single health system (SUS) in the Amazon Region, that is, involving phase III of cardiac rehabilitation with defined and structured protocols for the group of patients already mentioned. OBJECTIVE: To analyze the clinical evolution of patients in the postoperative period of coronary artery bypass grafting and / or valve replacement (phase III), in outpatient treatment. METHODOLOGY: It is a a longitudinal study, with quantitative variables to be performed in a single center within a year (12 months). Which will evaluate the effects of phase III cardiac rehabilitation of patients undergoing cardiac surgery through an evaluation, which will evaluate heart rate variability, functional capacity by six-minute walk test, pulmonary volumes and capacities by spirometry, percutaneous strength and ventilatory muscle, MRC scale and manovacuometry, respectively, and the application of a quality of life assessment questionnaire. Subsequently, the protocol of 20 sessions will be applied and at the end the same variables will be re-evaluated. EXPECTED RESULTS: It is expected from the application of this research that the protocol suggested for the phase III cardiac rehabilitation of patients submitted to cardiac surgery will bring benefits to patients, such as improvement in heart rate variability, improvement in functional capacity, improvement in quality of life, and reduction in morbidity and mortality rates.

NCT ID: NCT03771417 Recruiting - Clinical trials for Cardiovascular Diseases

Resistance Exercise and Low-Intensity Physical Activity Breaks in Sedentary Time to Improve Muscle and Cardiometabolic Health

REALPA
Start date: December 15, 2018
Phase: N/A
Study type: Interventional

What are the effects of resistance exercise (RE) alone or RE plus low intensity physical activity (LPA) breaks in sedentary time (ST) on skeletal muscle health in older adults? What are the effects of resistance exercise (RE) alone or RE plus low intensity physical activity (LPA) breaks in sedentary time (ST) on skeletal cardiometabolic health in older adults?

NCT ID: NCT03770312 Not yet recruiting - Clinical trials for Healthy Elderly Individuals With High LDL-cholesterol or Risk of Cardiovascular Disease

Low- and Moderate-intensity Statin and Clinical Outcome of Primary Prevention in Individuals Aged >75 Years: the SCOPE-75 RCT Study

Start date: December 10, 2018
Phase: Phase 4
Study type: Interventional

One of the most effective drug in the primary prevention of cardiovascular disease is statins. The protective effects of statin on developement of cardiovascular disease has been demonstrated in elderly individuals aged over 75 years. Since side effects of statin are more common in elderly individuals than in younger individuals, clinical guidelines recommend that use of low intensity statin is considered in elderly individuals. However, there are few randomized clinical trials evaluating the safety and efficacy of different intensity statins in elderly individuals. This is a multicenter, prospective, randomized clinical trial to compare efficacy and safety between low and high intensity statin for primary prevention of cardiovascular disease in elderly individuals.

NCT ID: NCT03763747 Not yet recruiting - Clinical trials for Coronary Artery Disease

Scoreflex NC - Scoring PTCA Catheter

Start date: January 30, 2019
Phase: N/A
Study type: Interventional

A prospective, open label, multi-center, single arm, observational study designed to evaluate the acute safety and device procedural success of the Scoreflex NC Scoring PTCA catheters in subjects with stenotic coronary arteries during percutaneous coronary intervention. Two-hundred (200) subjects will be treated at up to 15 U.S. sites with the Scoreflex NC Scoring PTCA catheter during their index procedure. All subjects will be screened according to the protocol inclusion and exclusion criteria and will be followed through hospital discharge.

NCT ID: NCT03760159 Enrolling by invitation - Clinical trials for Cardiovascular Diseases

Minimally Invasive Detection of a Sleep Apnoea

KCG_SLEEP
Start date: November 1, 2018
Phase:
Study type: Observational

Obstructive sleep apnoea (OSA) is characterised by recurrent nocturnal respiratory interruptions, resulting from the total or partial collapse of the upper respiratory ways. This results into sleep fragmentation, metabolic and biological disorders, which alter the neuropsychological and cardiovascular systems. Nowadays, 24% of men and 9% of women aged 30 to 60 years disclose already an asymptomatic and underdiagnosed sleep disorder breathing (SDB). In subjects suffering from cardiovascular disease, prevalence of SDB is higher than in the general population, reaching 87% in people with resistant hypertension, 51% in those with heart failure and 62% in those with atrial fibrillation (to cite a few).The current diagnostic tool for SDB is polysomnography (PSG), but this is an expensive, time-consuming and uncomfortable tool, which limits its wide-spread use despite the high frequency of SDB in general and, even more, in patients suffering from cardiovascular diseases. Several screening devices exist in order to test those patients at risk of SDB, but these have several limitations, since they are not recommended in patients who are asymptomatic for apnoea, in those with cardiorespiratory diseases, nocturnal arrhythmias or neurological and metabolic co-morbidities. In other words, nowadays there isn't an efficient screening tool of SDB, mainly for those with a low pre-test probability of having SDB. Preliminary evidence suggests that the seismocardiography (SCG) and the ballistocardiography (BCG) can detect nocturnal awakening and sleep disturbances with a good sensitivity and accuracy as compared to the state-of-the-art PSG. Simultaneous recording of SCG and BCG is called kinocardiography (KCG) and has not been performed yet during sleep. The main hypothesis tested in this study is that the KCG provides sensitive and accurate measures of obstructive and central apnoea as compared to the state-of-the-art PSG. The secondary hypotheses are related to modifications in the SCG and BCG signals during the apnoea and the effects of continuous positive air pressure (CPAP) therapy. These hypotheses will be tested through a series of studies in normal volunteers and patients, as follow: - Group RESPIRATOIRYSIMUL (Study A): voluntary end-expiratory breathing cessations periods and obstructive voluntary apnoea's (n=46); - Group SBD (Study B): patients admitted for complains of sleep disturbances without cardiovascular and/or respiratory abnormalities which could induce artifacts in the KCG recording (n=50); - Group nCPAP (Study C): patients treated by nCPAP therapy (n=50); - Group UNSELECTED (Study D): unselected consecutive patients (n=100), without recruitment restrictions. Study A is an interventional study on voluntary breath holding in normal volunteers. Studies B, C and D are observational investigations recruiting subjects referred for PSG as required by their medical condition. Because the KCG device is not intrusive, the investigators do not anticipate difficulties in the enrollment. This study will not affect in any manner the regular medical care of the patients admitted to the sleep laboratory. To conclude, SDB is a widespread disease with detrimental health effects and its prevalence is supposed to increase in future years. PSG is the gold standard for diagnosis of SDB but it is an expensive, uncomfortable and time-consuming tool, limiting its use in daily clinical practice. For subjects with a high pre-test probability of SDB, portable, inexpensive and easy-to-use tools have been proposed as sleep monitoring and seem to provide accurate estimates of SDB. Although such devices seem promising, they disclose also several limitations and are not universally accepted as SDB screening devices, mainly in case of low pre-test probability of SBD. The less cumbersome KCG may screen patients for SDB accurately. One of its unique features is also that it can directly identify the consequences of SDB and nCPAP therapy on the cardiovascular system, and in especially the presence of frequently associated cardiac arrhythmias. With a more efficient pre-screening, those who are most likely to be eligible for nCPAP therapy will have a better access to the currently existing sleep laboratory facilities. The present research project has thus the potential of improving SDB patients care and health, at no additional societal costs.

NCT ID: NCT03759002 Completed - Clinical trials for Cardiovascular Diseases

Association of Mean Platelet Volume and Cardiovascular Disease in Children With End Stage Renal Disease.

Start date: February 1, 2016
Phase:
Study type: Observational

Cardiovascular disease (CVD) is the major risk factor for death in end stage renal diseases (ESRD). Approximately 80% of ESRD patients have some degrees of left ventricular abnormalities at initiation of dialysis. Carotid intima media thickness (CIMT) has been widely accepted as an useful marker to assess CVD in ESRD children. In addition, cardiac mechanics parameters are used to evaluate cardiac function more precisely. However, measuring CIMT and cardiac mechanics parameters are expensive and difficult to perform as a routine method. Mean platelet volume (MPV) is a hematological index which shows the size of platelets. Uremic state causes inflammatory condition that affects MPV. Previous studies on people with normal renal function have shown that this parameter can also have association with CVD. However the data in children with ESRD is scarce. The aim of this study is to find a simple hematologic marker to use regularly in ESRD children finding patients at risk of CVD. Therefore, we will investigate the relationship between mean platelet volume and CIMT and cardiac mechanic parameters in children with ESRD.

NCT ID: NCT03757845 Not yet recruiting - Clinical trials for Cardiovascular Diseases

Effects of Mediterranean Diet Intervention in Diabetic Heart Disease

Start date: December 15, 2018
Phase: N/A
Study type: Interventional

Diabetes Mellitus (DM) is a global epidemic associated with inflammation, aggressive atherosclerosis and increased risk for, and severity of, coronary artery disease. Strategies to improve glycemic control with insulin and/or oral hypoglycemic agents have not impacted cardiovascular morbidity and mortality in type II DM patients with known heart disease. The Investigators have found that the typical "Western" diet, which is high in saturated fats, such as the lipid palmitate, but low in unsaturated fats, such as the lipid oleate, results in changes to cell membrane lipid content and disruptions to membrane functional domains -called caveolae- that are associated with insulin resistance and metabolic dysfunction. In mice, the investigators found that palmitate induces both systolic and diastolic contractile dysfunction. They have demonstrated, in cell cultures, that oleate prevents palmitate-induced cell dysfunction. This may explain how a diet rich in unsaturated fats and plant-derived flavonoids, such as the "Mediterranean" diet, can counter the adverse cardiovascular effects of DM. This study builds in these prior findings and its central hypothesis is that, in DM, a Mediterranean diet can induce rapid changes in cardiac cell membrane lipid composition and signaling. This is a randomized dietary intervention in DM subjects scheduled for coronary artery bypass grafting (CABG) surgery, to examine the effects of a short-term modified Mediterranean diet (ModMeD), compared to the standard cardiac DM diet (SCaDMD), on receptor tyrosine kinase signaling, serum and cellular lipid content, and membrane/caveolae function.

NCT ID: NCT03757156 Not yet recruiting - Clinical trials for Healthy Participants With Moderate and High Cardiovascular Risk

Aspirin Withdrawal and Clinical Outcome in Patients With Moderate to High Cardiovascular Risk But Without Cardiovascular Disease

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

While the efficacy of aspirin for the secondary prevention of cardiovascular disease is evident, the effect of aspirin for primary prevention is unclear. The use of aspirin reduces cardiovascular mortality and myocardial infarction but increases side effects such as bleeding. Therefore, the use of aspirin for primary prevention in people without cardiovascular disease should be determined by individual risk and clinical benefit. The European guidelines have been changed to not recommend aspirin use in people without cardiovascular disease, but there are still people taking aspirin for primary prevention. The purpose of this study is to investigate the effect of aspirin withdrawal on cardiovascular events in patients without cardiovascular disease. This is a single center, prospective, randomized clinical study evaluating the safety and efficacy of withdrawal of aspirin among patients with moderate or high cardiovascular risk.

NCT ID: NCT03752060 Not yet recruiting - Inflammation Clinical Trials

The Clinical Utility of Resistance Training for Improving Cardiovascular Disease Risk in Post-Menopausal Women

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

Given the heightened cardiovascular disease (CVD) risk in post-menopausal women, studies are needed to explore novel, feasible methods for reducing risk in this population. Based on prior data, primarily in other populations, progressive resistance training is a promising candidate. This project will test the effectiveness of a practical, progressive resistance training regimen for lowering numerous CVD risk factors compared to both aerobic training and no exercise in post-menopausal women.

NCT ID: NCT03749499 Not yet recruiting - Hypertension Clinical Trials

Targeting of UnControlled Hypertension in Emergency Department

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

The proposed project underscores the following: 1) The prevalence of uncontrolled/undiagnosed hypertension (HTN) in underrepresented groups presenting to the ED is alarmingly high, and 2) ED engagement and early risk assessment/stratification is a cost-effective, feasible innovation to help close health disparity gaps in HTN. This proposal involves a two-arm randomized controlled trial of up to 770 patients from the Emergency Department at University of Illinois Hospital with elevated blood pressure (BP). The primary objective is to determine the effectiveness of an emergency department-initiated Educational and Empowerment (E2) intervention with a Post Acute Care Hypertension Consultation (PACHT-c) intervention (arm 2) on the primary outcome of mean systolic blood pressure (SBP) differences between the two trial arms at 6-months post intervention. Secondary objectives include evaluating the effectiveness of this ED education and empowerment intervention on mean SBP and diastolic blood pressure (DBP) differences at 3-months, and mean DBP differences at 6-months. Additionally improvement in cardiovascular risk score (as measured by the Atherosclerotic Cardiovascular Disease (ASCVD) Risk Score), medication adherence (as measured by the Modified Morisky Scale), primary care engagement (measured by compliance with outpatient follow-up appointments), HTN knowledge improvement (as measured by a validated HTN knowledge survey), and overall patient motivation (as measured by the Patient Activation Measures (PAM) will also be assessed as part of this study.