Clinical Research Directory

Fractional Flow Reserve and Instantaneous Free-wave Ratio Revascularization Strategies in Women

A real world study to evaluate outcomes in women based on guideline identified fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR) cutoffs for ischemia (ischemia defined as FFR ≤ 0.80 and iFR ≤ 0.89).

Evaluating New Radiation Techniques for Cardiovascular Imaging

Title: Evaluating New Radiation Techniques for Cardiovascular Imaging Background: Cardiac CT angiography is associated with radiation exposure. Different methods of creating CT pictures have been developed to reduce the radiation dose to the subject. The purpose of this research study is to learn whether these low dose research imagings are accurate or predict subject outcomes. Cardiac CT is also used for diagnostic imaging of coronary artery disease and identification of abnormal cardiac structures. An additional purpose of this study is to monitor the progression of cardiac disease. Cardiac imaging software and AI are constantly evolving and requires validation for accuracy. Using existing scan data, updated image software reconstruction can be applied and compared to previous existing standard of care images. Objectives: \- To study new ways of taking pictures of the heart or blood vessels using computed tomography. Eligibility: \- Adults at least 18 years of age who will be having imaging studies to help detect heart or blood vessel problems. Design: * Participants will be screened with a physical exam and medical history. Blood samples will be taken to check kidney function. * Participants will have a CT scan of the heart and blood vessels. A contrast agent may be used to improve the quality of the images. The scanning session may last up to 2 hours. * Timing of and the need for follow up contact will depend on results from the initial scan and may be repeated to assess for late events. Telephone, office contact, or other follow-up of subjects may be done after CCTA to evaluate if the subject had subsequent cardiovascular testing. Further follow up will be based on reported test results.

Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold (RMS) System in Subjects With Coronary Artery Lesions

The objective of this study is to assess the safety and efficacy of the Freesolve resorbable magnesium scaffold (RMS) in the treatment of subjects with up to two de novo lesions in native coronary arteries compared to the Xience coronary drug-eluting stent (DES) system

European Survey of Cardiovascular Disease Prevention, Diabetes and Chronic Kidney Disease (EUROASPIRE VI)

The goal of this observational study is to provide a unique European picture of preventive action by cardiologists, other specialists and primary care physicians looking after patients with coronary heart disease (CHD), individuals at high cardiovascular disease risk and all those with hypertension, dyslipidaemia (including familial hypercholesterolaemia), diabetes and dysglycaemia and chronic kidney disease (CKD) and determine whether the European guidelines on cardiovascular disease prevention, hypertension, lipids, diabetes and chronic kidney disease are being followed.

Fibroblast Growth Factor-1 (FGF-1) for the Treatment of Coronary Heart Disease

Treatment for no-option heart patients with coronary artery disease. Procedure includes the injection into the heart of a protein growth factor, administered by the Biological Delivery Systems MyoStar injection and mapping catheters, to stimulate the growth of blood vessels around blocked coronary arteries.

Hybrid Sirolimus-eluting Versus Everolimus-eluting Stents for Total Coronary Occlusions

Percutaneous recanalization of total coronary occlusions (TCO) was historically hampered by high rates of restenosis and reocclusion. In the PRISON II and III trial we showed landmark reduction in restenosis with sirolimus-eluting stents (Cypher, Cordis Corporation) compared to conventional bare metal stents in TCO. In the PRISON III trial, we observed similar favourable results with second-generation zotarolimus-eluting stent (Resolute, Medtronic Inc.). Another drugs-eluting stent mounted with everolimus (Xience Prime, Abbott) also demonstrated favourable results in TCO. Recently, drug-eluting stents (DES) with bioresorbable polymer coatings were developed, to address safety concerns regarding the observation of very late stent thrombosis, due to hypersensitivity reactions, and chronic inflammation, on the durable polymer coating of DES. However, none of these DES with bioresorbable polymers were evaluated in patients with TCO. The PRISON IV trial is a prospective, randomized, single-blinded, multi-center trial, designed to evaluate the safety, efficacy, and angiographic outcome of hybrid sirolimus-eluting stents with bioresorbable polymers (ORSIRO, Biotronik Inc.) compared to everolimus-eluting stents with durable polymers (Xience Prime, Abbott) in patients with successfully recanalized TCOs.

Prospective Multicenter Registry On Radiation Dose Estimates Of Cardiac CT Angiography in Daily Practice in 2017 (PROTECTION VI)

Background: CCTA is a common way to evaluate coronary artery disease. It stands for coronary computed tomography angiography. It uses scanning to look at the arteries that supply blood to the heart. It is noninvasive, widely available, and generally accurate. But it does expose people to radiation. Exposure to high amounts of radiation can increase a person s risk of getting cancer. Researchers want to learn more about the relationship between CCTA and radiation exposure. Objective: To see how much radiation is used to take pictures of the heart and how measures to reduce radiation are used around the world. Eligibility: People ages 18 years and older who need a computed tomography (CT) scan of the heart Design: Participants will be screened with a review of their medical records. Participants may have a pregnancy test. Participants will have the scheduled scan. Small, sticky discs will be placed on the chest. A small tube will be placed into a vein in the arm. A contrast material (dye) will be given through it. Participants will lie on the CT scanning table. A CCTA scan usually takes about 15 minutes if the heart rate is slow and steady.

Coronary Sinus Reducer Implantation in Patients With Ischaemia and Non-obstructed Coronary Arteries and Coronary Microvascular Dysfunction.

To demonstrate the feasibility and efficacy of the CS Reducer for the treatment of patients with ischaemia and non-obstructed coronary arteries (INOCA) and coronary microvascular dysfunction (CMD) and through a nested mechanistic substudy investigate the physiological responses in the coronary microcirculation responsible for changes in myocardial perfusion.

Evaluation of a Prototype Smartphone Application of Personalized Care for Coronary Artery Disease

This project will benefit from the results of the concept study conducted from July to October 2014 from groups of coronary patients. This first study will help to develop the precise contours of Appet HEART application for the production of the prototype version used in the clinical feasibility study. The objectives of the feasibility study are: 1. assess the rate of use of the application 2. to determine the ideal target population of the application 3. to evaluate the effectiveness of the application 4. to measure the risks and potential limitations of its use 5. to determine the medical and economic impact of this application

Nurses' Health Study (Cardiovascular Component)

To determine the relationships of hormonal, reproductive, dietary, and lifestyle factors, as well as biochemical and genetic factors, with the subsequent risk of coronary heart disease and other cardiovascular events in a cohort of female registered nurses. The current funding cycle involves comprehensive metabolomic profiling of coronary heart disease cases and controls and development of metabolomic risk scores for coronary heart disease.

Treatment of Functionally Non-significant Vulnerable Plaques in Patients With Multivessel ST-elevation Myocardial Infarction The VULNERABLE Trial

The study aims to compare a preventive percutaneous coronary intervention (PCI) plus optimal medical treatment (OMT) strategy vs. OMT for treatment of non-functionally significant non-culprit lesions presenting with optical coherence tomography (OCT) findings indicative of vulnerable plaque, in patients with ST-elevation myocardial infarction (STEMI) and multivessel disease.

Interventional Strategy for Non-culprit Lesions With Major Vulnerability Criteria at OCT in Patients With ACS

The INTERCLIMA (Interventional Strategy for Non-culprit Lesions With Major Vulnerability Criteria Identified by Optical Coherence Tomography in Patients With Acute Coronary Syndrome) is a multi-center, prospective, randomized trial of optical coherence tomography (OCT)-based versus physiology-based (i.e. fractional flow reserve\[FFR\]/instantaneous Wave-Free Ratio\[iFR\]/resting full-cycle ratio\[RFR\]) treatment of intermediate (40-70% diameter stenosis), non-culprit coronary lesions in acute coronary syndrome (ACS) patients undergoing coronary angiography. About 1420 patients with ACS will be randomized into the study at approximately 40 sites worldwide.

Assessing Outcomes of Enhanced Chronic Disease Care Through Patient Education and a Value-based Formulary Study

The purpose of this study is to determine the effect of two novel interventions; (1) a value-based formulary which eliminates copayment for selected high-value medications (proven to prevent heart attacks, stroke, and hospitalizations); and (2) a comprehensive patient education program aimed at lifestyle modification and optimal drug use, combined with relay of information on medication use, on the risk of adverse clinical outcomes (mortality, heart attack, stroke, need for coronary revascularization, and chronic disease related hospitalizations) in low-income seniors with chronic conditions over three years of follow-up or until March 31, 2021 (whichever comes first).

University of North Carolina Alumni Heart Study

To continue surveillance of the participants in the University of North Carolina Alumni Heart Study, which tests the hypothesis that hostility and related psychosocial factors are involved in the pathogenesis of coronary heart disease.

Trial of Orbital Atherectomy Versus Standard Strategy in Calcified Bifurcation Lesions

Clinical research with medical devices indicated in accordance with the CE marking, led by researchers, multicenter, open, prospective, randomized and controlled. Patients are randomized to treatment with a conventional balloon and then a coronary stent or to initial plaque modification with Orbital Atherectomy (OA) and then a coronary stent. To evaluate the efficacy and safety of OA in the adequate treatment with coronary stent of the calcified bifurcation lesion using angiography and optical coherence tomography (OCT).

Prognostic Accuracy of the HEART Score in Undifferentiated Chest Pain: A Multicenter Validation Study

Chest pain remains one of the most common, potentially serious presenting complaints for adults emergency department visits with approximately 7.6 million yearly visits in the united states. The priority for emergency physician is to determine whether these patients with acute chest pain have a potential life threatening underlying etiology. The great challenge is to differentiate patients presenting with acute coronary syndrome and those with other more benign conditions. There is a global tendency for ED physician to over investigate chest pain patients , even in low-risk patients. This kind of practice leads to resource over-utilization and a huge health costs waste contrasting with no outcomes improvement. For many years, physicians have been searching tools, ranging from specific diagnostic tests to entire strategies of evaluation, to appropriately stratify the risk in patients with chest pain in order to simultaneously prevent major adverse cardiac events and reduce unnecessary testing and hospitalizations. Many bioclinical scores have been developed, such as the TIMI score and the GRACE score.The HEART score is one of the more recently proposed model derived through a process involving expert opinion and review of medical literature. It is calculated based on admission data of medical history, EKG, age, cardiovascular risk factors and troponin levels. The HEART score was created specifically to identify ED patients presenting with undifferentiated chest pain who were at low risk as well as patients at high risk of short-term MACE occurrence. HEART score has been widely reported to outperform the TIMI and the GRACE scores. Several scientific societies are encouraging the use of HEART score, for evaluating patients with chest pain suggestive of ACS in the ED. The goal of our investigation is to validate HEART score as a prognostication tool among ED patients with chest pain in teaching hospitals in Tunisia.

IRIS- DESyne X2 in the IRIS-DES Registry

This study evaluates effectiveness and safety of DESyne X2 in Routine Clinical Practice.

A Study Comparing Standard Care for Diabetes to Case-managed Care for Diabetes in Patients With Coronary Artery Disease

The purpose of this study is to compare two ways to treat patients with Type 2 Diabetes, Standard Care or Case-Managed Care. In-Patient Standard Care is guided by the assigned cardiologist and Out-Patient Standard Care by the existing diabetes care givers. Case-Managed care involves a consult with an endocrinologist and counseling from a diabetic educator and a dietician.

PK(Pharmacokinetic) Papyrus Covered Coronary Stent System

The PK Papyrus Covered Coronary Stent System is a coronary stent being used at Methodist Dallas Medical Center for patients with coronary perforations.

Soy Food and Coronary Heart Disease in Women

To investigate whether soy food intake reduces risk of non-fatal myocardial infarction (MI) and fatal coronary heart disease in Chinese women.

Digital Implementation of the German S3 Clinical Practice Guideline for Multimorbidity

The web application gp-multitool.de is a digital tool for implementing the German S3 clinical practice guideline for multimorbidity of the German Society of General Practitioners and Family Physicians in primary care. The tool enhances evidence-based and patient-centered care by assessing and providing information relevant for the primary care of this patient group. This cluster-randomised clinical evaluation study examines the effectiveness of an intervention based on gp-multitool.de in general practitioner (GP) practices in Germany.

Chronical Illness-related Limitations of the Ability to Cope With Rising Temperatures, Third Wave

The CLIMATE-III Observational Study examines to what extent chronically ill patients experience adverse health effects because of heat and whether the patients' specific health behavior, somatosensory amplification, risk and benefit perception, self-efficacy, health literacy, and the degree of urbanisation of the patients' administration district are associated with these effects. Study participants from Germany and Italy will be included in the sample.

The International Survey of Acute Coronary Syndromes-ARCHIVES

ISACS ARCHIVES network is part of ISACS TC (NCT01218776) health care program. It is a collaborative network of research centers that support the rapid development of new scientific information and analytic tools. The ISACS ARCHIVES network assists health care providers, scientists, and policymakers seeking unbiased information about the outcomes, clinical effectiveness, safety, and appropriateness of health care items and services, particularly prescription medications and medical devices in acute coronary syndromes (ACS).

CRIC Combined With MFT for MFR in Patients With Incomplete Revascularization of CAD

The main objective of this study is to demonstrate whether the combination of chronic remote ischemic conditioning and mindfulness therapy can improve myocardial flow reserve in patients with incomplete revascularization of coronary artery disease.