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Coronary Artery Disease clinical trials

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NCT ID: NCT02198872 Not yet recruiting - Clinical trials for Arteriosclerosis, Coronary

Aquatic and Land Aerobic Training, Cardiorespiratory and Metabolic Variables in Cardiorespiratory Diseases

Start date: September 2014
Phase: Phase 0
Study type: Interventional

In the pathophysiological process of coronary artery disease (CAD), are present, autonomic dysfunction and reduced functional capacity. Studies showed that physical training (PT) is critical in the treatment of CAD by promoting beneficial effects. Although water based exercises program have been documented in patients with various cardiovascular diseases, the most of studies among patients with CAD used land based exercises programs. OBJECTIVE: To evaluate and compare the effects of aerobic water (WPT) and land (LPT) based PT on autonomic modulation of heart rate (HR), body composition and cardiorespiratory and metabolic variables in patients with CAD. METHODS : 40 men between 50 and 70 years old with CAD diagnosed by coronary angiography showing obstruction greater than 50% and underwent angioplasty will be evaluated in 4 stages; 1) immediately after angioplasty, clinical assessment, body composition analysis and recording of HR and NN intervals during rest. 2) The components of step 1) will be repeated after three month, adding the record of HR and NN before, during and after the Valsalva maneuver, spirometry and cardiopulmonary exercise testing. 3) Volunteers will be randomly divided into two groups, WPT and LPT for 48 sessions. 4) The components of step 2) are repeated after each period of 12 sessions. Thus, it is expected that WPT promote beneficial physiological adaptations in CAD patients with obstruction greater than 50%.

NCT ID: NCT02198716 Completed - Clinical trials for Coronary Artery Disease

Xience or Vision Stent Management of Angina in the Elderly

XIMA
Start date: November 2008
Phase: N/A
Study type: Interventional

The treatment of complex coronary disease causing limiting symptoms of angina with drug-eluting stent technology will prove superior to bare metal stent technology, with respect to a combined endpoint of mortality, MI, requirement for target vessel revascularisation and severe haemorrhage, in patients aged 80 or above.

NCT ID: NCT02198300 Completed - Clinical trials for Coronary Artery Disease

DES Versus BiOSS LIM - POLBOS II Study

POLBOS II
Start date: November 2012
Phase: Phase 4
Study type: Interventional

Coronary bifurcation lesions pose therapeutic problems during percutaneous coronary interventions (PCI) and are associated with higher rates of periprocedural complications as well as higher rates of in-stent restenosis and stent thrombosis. Provisional T-stenting (PTS) is the best treatment strategy at the moment. However, the optimal approach to coronary bifurcations treatment is still a subject of debate, especially when the side branch is large, not easily accessible and narrowed by a long lesion. One of the proposed alternatives are dedicated bifurcation stents (DBS). However, there is large scarcity of randomized trials with DBS. POLBOS II study is continuation of POLBOS I (POLish Bifurcation Optimal Stenting) study, in which paclitaxel-eluting stent BiOSS Expert® (Balton, Poland) was assessed. Now performance of sirolimus-eluting stent BiOSS LIM® (Balton, Poland) is verified.

NCT ID: NCT02197065 Completed - Inflammation Clinical Trials

Pilot Study of Atorvastatin for Orthopedic Surgery Patients

POST-OP Pilot
Start date: September 2014
Phase: Phase 2
Study type: Interventional

Up to 35% of hip fracture patients have been shown to experience heart injury after surgery, and as many as 10% have a heart attack or die in the three months after surgery. Hip and knee arthroplasty patients are also at risk of cardiovascular complications. Patients who have these complications have higher levels of inflammation postoperatively. Statins (such as atorvastatin/Lipitor) lower cholesterol and also lessen inflammation. Both of these effects are important in preventing heart attacks. Statins have been shown to reduce the risk of heart attacks in non-surgical patients, and to protect from heart attacks in patients having heart surgery. Whether statins can prevent heart attacks in orthopedic patients is not known. In this pilot study the investigators will treat 30 orthopedic surgery patients (hip fracture, hip or knee arthroplasty) with either atorvastatin or placebo (a capsule with no study drug). Patients will start the study drug prior to surgery and take it for 45 days after surgery. Neither the doctors nor the patients will know whether they are taking atorvastatin or placebo. The investigators will look for evidence of inflammation and heart injury after surgery. The investigators hypothesize that atorvastatin will lessen the degree of postoperative inflammation found in these patients. In this study, the investigators will use a very sensitive test of heart injury that can detect problems even when patients have no symptoms. The investigators hypothesize that this test will demonstrate silent heart injury in over 50% of the hip fracture patients and over 30% of arthroplasty patients in our study. The results of this trial will help us to develop a larger study in 1000 hip fracture and joint replacement patients to determine whether atorvastatin protects orthopedic surgery patients from heart injury and other complications of surgery.

NCT ID: NCT02195414 Active, not recruiting - Clinical trials for Coronary Artery Disease

NeoVas Bioresorbable Coronary Scaffold First-in-Man Study

Start date: July 2014
Phase: Phase 1
Study type: Interventional

The NeoVas First-in-Man study is a prospective, two centers, single arm trial, which will enroll a total of 30 patients. The hypothesis of this study is to evaluate clinical feasibility, safety, and efficacy of NeoVas sirolimus-eluting bioresorbable coronary scaffold in the treatment of patients with de novo coronary lesion.

NCT ID: NCT02193971 Active, not recruiting - Clinical trials for Acute Coronary Syndrome

Harmonizing Optimal Strategy for Treatment of Coronary Artery Diseases Trial - Comparison of REDUCTION of PrasugrEl Dose & POLYmer TECHnology in ACS Patients (HOST REDUCE POLYTECH RCT Trial)

Start date: July 2014
Phase: Phase 4
Study type: Interventional

- Study objectives 1. To compare the safety and long-term efficacy of coronary stenting with biostable polymer drug-eluting stent (Promus PremierTM, Xience Alpine®, Resolute Onyx®) with biodegradable polymer drug-eluting stent (Biomatrix®, Biomatrix Flex®, Nobori®, Ultimaster®, Synergy ® and Orsiro®) in patients with acute coronary syndrome 2. To compare the efficacy and safety of 5 mg prasugrel maintenance therapy compared with 10 mg prasugrel maintenance therapy in patients with acute coronary syndrome undergoing percutaneous coronary intervention - Study design : Prospective, open-label, 2-by-2 multifactorial, randomized, multicenter trial to test the following in CHD patients 1. Non-inferiority of biostable polymer drug-eluting stent (Promus PremierTM, Xience Alpine®, Resolute Onyx®) compared with biodegradable polymer drug-eluting stent (Biomatrix®, Biomatrix Flex®, Nobori®, Ultimaster®, Synergy ® and Orsiro®) in terms of patient-oriented composite outcome 2. Non-inferiority of 5 mg compared to 10 mg dose of prasugrel maintenance in terms of major adverse cardiovascular events

NCT ID: NCT02192840 Completed - Clinical trials for Coronary Artery Disease

POLish Bifurcation Optimal Stenting Study

POLBOS
Start date: October 2010
Phase: Phase 4
Study type: Interventional

Coronary bifurcation lesions pose therapeutic problems during percutaneous coronary interventions (PCI) and are associated with higher rates of periprocedural complications as well as higher rates of in-stent restenosis and stent thrombosis. Therefore the optimal approach to coronary bifurcations treatment is still a subject of debate, especially when the side branch is large, not easily accessible and narrowed by a long lesion. One of the proposed alternatives are dedicated bifurcation stents (DBS). However, there is large scarcity of randomized trials with DBS. The aim of POLBOS I (POLish Bifurcation Optimal Stenting) study was to compare two intervention strategies for bifurcation treatment: provisional T-stenting (PTS) with any regular drug-eluting stent (rDES), the best treatment strategy at the moment, with stenting of bifurcation lesions with dedicated bifurcation paclitaxel-eluting stent BiOSS Expert® (Balton, PL).

NCT ID: NCT02191306 Completed - Clinical trials for Evaluate the Relationship Between HIV Medications and Coronary Atherosclerosis

Utilizing Computed Tomographic Angiography to Evaluate Coronary Artery Disease in Patients on Long-Term Antiretroviral Therapy

Start date: October 2013
Phase:
Study type: Observational [Patient Registry]

Utilizing Computed Tomographic Angiography to Evaluate Coronary Artery Disease in Patients on Long-Term Antiretroviral Therapy Intro: It is well known that HIV treated with antiretroviral drugs increases the risk for coronary artery disease. Studies have documented this with various methods including analyzing the effects of retroviral therapy on cardiac risk factors such as diabetes, lipids and hypertension. Still other studies have looked at carotid and brachial artery intimal thickness. Our study, then, aims to evaluate the relationship between HIV medications and coronary atherosclerosis using a novel method. Coronary artery CT angiography is a relatively new diagnostic procedure to evaluate heart disease in cardiac patients. We will apply this test to HIV patients on longstanding antiretroviral therapy to directly examine their coronary arteries to assess heart disease. Hypothesis: We hypothesize that HIV patients on antiretroviral therapy will have increased coronary artery disease compared to the general population. Methods: This project will be conducted in collaboration between Florida Heart Center and Associates in infectious Disease - two communities based infectious disease and cardiology practices. We will identify all the HIV positive patients seen within a 1 month timeframe at the infectious disease office. These patients will then be filtered by our exclusion/inclusion criteria. After obtaining informed consent, we will draw blood from each patient to gather lab values such as A1C, cholesterol, inflammatory markers, and other markers associated with coronary artery disease. Each enrolled patient will then schedule and receive a 64 slide coronary CTA at Florida Heart Center. The results of the CTA scans will be categorized in mild, moderate, and severe coronary artery disease. The data, then, will consist of the parameters measured on blood work, and the results of the coronary CTA. Inclusion Criteria: 1. Patients aged 35 to 50 with HIV and on retroviral therapy for at least 5 years. Exclusion Criteria: 1. Patients with prior documented coronary artery disease, heart attack, stent placement, or heart surgery. Statistical Analysis: We will conduct a multivariate analysis on the cardiac risk factors taken from patient history and the bloodwork (diabetes, lipids etc) to correlate them with the results of the CTA. We will also conduct basic analysis to support our hypothesis that long term antiretroviral therapy increases coronary artery disease. Funding: The bloodwork and CTA tests ordered in this study will be payed for by insurance companies where available. In cases where insurance companies will not pay, Florida Heart Center will pay for the CTA tests and Associates in infectious Disease will fund the bloodwork. Humans Subjects Protection: This will be a projective chart review study that will require access to protected health information. Thus, we will seek full IRB approval from the FSU IRB committee with informed consent. An informed consent document will be given to each patient explaining all the risks and benefits of the study in addition to the methods. Recruitment will be done by an office staff or medical assistant not on the research team. After patient recruitment, their medical records will be flagged for study and they will undergo the required testing. At completion of testing, their results will be recorded in the final data sheet, and their medical record will no longer be flagged for study. No identifying data will be recorded in the final data sheet, and the data will be stored in an encrypted excel sheet on a secure password protected personal laptop running antivirus and firewall. Third parties (such as family members) will not have access to any research data regardless of authorizations received from the study subjects. All the test results and labwork performed for the study will go into the patient's individual medical record at their respective offices. Thus, if an authorized third party wishes to view any test results, they can do so via the normal methods at the doctor's office.

NCT ID: NCT02189499 Active, not recruiting - Clinical trials for Coronary Artery Disease

Feasibility Study of the Amaranth Medical FORTITUDE Bioresorbable Drug-Eluting Coronary Stent

MEND II
Start date: September 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and feasibility of a new coronary artery stent for treating blockages in the arteries supplying blood to the heart muscle. The Amaranth FORTITUDE scaffold releases a drug (sirolimus) to reduce the likelihood of the treated blood vessel developing a new blockage. In addition, the scaffold dissolves away over time, leaving no permanent implant after the blood vessel has healed. This study will will be the first evaluation of this stent in humans.

NCT ID: NCT02189070 Completed - Clinical trials for Coronary Artery Disease

The PAtient Preference Analysis of Yearly Follow-up After PCI (PAPAYA)

PAPAYA
Start date: July 2013
Phase: N/A
Study type: Observational [Patient Registry]

The purpose of this study is to determine the preference of patients regarding the approach for follow-up after percutaneous coronary intervention (PCI) procedures. We hypothesize that patients prefer questionnaires for annual follow-up assessment when compared to telephone or email.