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Coronary Disease clinical trials

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NCT ID: NCT03324308 Withdrawn - Clinical trials for Coronary Artery Disease

Dynamic Computed Tomography Myocardial Perfusion Imaging for Detection of Coronary Artery Disease

Start date: March 30, 2018
Phase: N/A
Study type: Interventional

Coronary artery computed tomographic angiography (CTA) is a widely used, highly accurate technique for the detection of coronary artery disease (CAD), with sensitivity and negative predictive values of over 90% (1-4). Patients with normal CTA findings have an excellent prognosis and do not require further testing for CAD (5). However, like invasive coronary angiography (QCA), CTA is an anatomic test and, unless lesions are very severe (>90% stenosis), cannot reliably predict the impairment of flow (functional significance) of intermediate grade stenoses. For this reason, in approximately 15-25% of patients, additional functional testing may be required after CTA, usually in the form of stress testing (6-8). Stress testing is commonly done by exercise or pharmacologic stress with electrocardiographic monitoring and often, imaging of myocardial perfusion by nuclear scintigraphy (MPI) or detection of abnormal contraction by echocardiography. This requires a separate procedure, entailing time, expense and limited risk. Furthermore, in patients with previously known CAD, CTA alone is not an adequate test, because in most cases there are multiple lesions that are possible sources of ischemia. Over the last 10 years, these investigators and others around the world have developed a method of imaging myocardial perfusion by CT (CTP). This test is an adjunct to the usual Cardiac Computed Tomography Angiography (CCTA) procedure and can be done immediately thereafter, using conventional pharmacologic stress agents. It has demonstrated accuracy in many single center trials, and in this large multicenter study, the CORE320 trial (9,10) which showed a high accuracy in predicting the combined results of QCA plus MPI testing and a second multicenter trial established non-inferiority of myocardial CTP compared with nuclear stress testing (11,12). Additionally, this investigator group has published a direct comparison of diagnostic performance of myocardial CTP imaging and SPECT myocardial perfusion imaging and demonstrated superior diagnostic performance of CTP imaging compared with SPECT for the diagnosis of significant disease on invasive angiography (13). CTP images can be acquired with two different approaches: static or dynamic. In the CORE320 study, the CTP protocol used static acquisition method. The static CTP method, samples a snapshot of the iodine distribution in the blood pool and the myocardium over a short period of time, targeting either the upslope or the peak of contrast bolus. The notion behind this is that, at the upslope of the contrast, the difference in attenuation value of the ischemic and remote myocardium is at the maximum which enables for qualitative and semi-quantitative assessment of myocardial perfusion defects. The static CTP, however, does not allow for direct quantification of the myocardial blood flow (MBF). One of the drawbacks of static CTP lies in the acquirement of only one sample of data and the possibility of mistiming of the contrast bolus that results in poor contrast-to-tissue ratios by missing the peak attenuation (14). Output and flow rate of the contrast material may affect bolus timing. In addition, the acquisition of data from sequential heartbeats affects the attenuation gradient and may result in a heterogeneous iodine distribution, mimicking perfusion defects (15). Furthermore, the static CTP is limited in detection of balanced ischemia, where the perfusion of the entire myocardium is impaired and therefore there is no reference remote myocardium for comparison for semi-quantitative or qualitative static methods of CTP interpretation. Dynamic CT perfusion imaging uses serial imaging over time to record the kinetics of iodinated contrast in the arterial blood pool and myocardium. This technique allows for multiple sampling of the myocardium and the blood pool and creating time attenuation curves (TAC) by measuring the change in CT attenuation over time. Mathematical modelling of TACs permits for direct quantification of MBF. Despite its advantages, the use of dynamic CTP were limited in the past. A high temporal resolution and high number of detectors are required for dynamic CTP to allow for entire myocardial coverage, and in order to obtain multiple consecutive images at high heart rates(16,17). But the main challenge of dynamic CTP acquisition was the high radiation dose associated with this technique. Nevertheless, with the introduction of the cutting-edge 320 detector CT scanning systems with fast gantry rotation the issue of the cardiac coverage is eliminated(17). The second-generation 320-row scanners also permit the quantification of the MBF with dynamic CTP acquisition with relatively low-dose of radiation(18,19). In this study the investigators aim to evaluate the feasibility, safety and accuracy of the low-radiation dose dynamic myocardial CT perfusion compared to static CTP approach to detect hemodynamically significant coronary artery disease.

NCT ID: NCT03257683 Withdrawn - Clinical trials for Severe Coronary Artery Disease

RANOLAZINE STUDY: Speckle Tracking Derived Myocardial Strain

Start date: April 14, 2017
Phase:
Study type: Observational

The purpose of this study is to collect data to determine if the medication, Ranolazine, effects heart muscle function in patients who have areas of non-revascularizable heart muscle.

NCT ID: NCT03236415 Withdrawn - Clinical trials for Coronary Artery Disease

Comparative Response to Vascular Injury in Patients With Diabetes Mellitus: An OCT Study of BVS Versus Xience DES

Start date: August 2017
Phase: N/A
Study type: Interventional

Stents are used at centers around the world to unblock the arteries of the heart. These stents are usually made of metal and remain permanently within the blood vessel wall. Newer developments in the stent technology has led to stent scaffolds that can be reabsorbed over time. Patients with diabetes are prone to more complex blockages in the heart arteries which can be more difficult to treat. The purpose of this study is to compare the difference of how arteries heal early when metal stents or resorbable stents are used in patients with diabetes.

NCT ID: NCT03184155 Withdrawn - Clinical trials for Coronary Artery Disease

Prevention of Coronary Microvascular Dysfunction Post-PCI by Intracoronary Nicardipine

Start date: December 2025
Phase: Early Phase 1
Study type: Interventional

This is a single-center double blind, placebo controlled study of patients undergoing a cardiac catheterization where the need for a percutaneous coronary intervention (PCI) is anticipated or will be determined during the early diagnostic phase. The study will assess the use of intracoronary nicardipine vs. sterile saline injection in reducing the index measurement of microcirculatory resistance (IMR). Fifty consecutive patients presenting to the Thomas Jefferson University (TJUH) Cardiac Catheterization lab will be randomized in a 1:1 fashion to receive either intracoronary nicardipine or sterile saline injection prior to PCI. IMR values will be assessed pre and post procedure. Data on clinical outcomes and adverse events will be collected by phone at 30 days and 1 year following the procedure.

NCT ID: NCT03105219 Withdrawn - Clinical trials for Diabetic Kidney Disease

IvaBradinE to Treat MicroalbumiNuria in Patients With Type 2 Diabetes and Coronary Heart Disease

BENCH
Start date: July 1, 2017
Phase: Phase 3
Study type: Interventional

To explore the efficacy of Ivabradine for the treatment of microalbuminuria in patients with type 2 diabetes and coronary heart disease.

NCT ID: NCT03042117 Withdrawn - Clinical trials for Cardiovascular Diseases

Connecting Periodontal and Coronary Artery Disease Via the Inflammatory State of the Body

Start date: October 18, 2016
Phase:
Study type: Observational

Cardiovascular disease is one of the leading causes of death in the United States and the world. Many interventions relating to prevention have been emphasized as more risk factors for this devastating disease are discovered. Periodontal disease is known to have a close association with cardiovascular disease, but its role as a risk factor is still not well understood. Inflammation is a driving force in both of these diseases, creating a potential bridge between the two. Specifically, periodontal disease can cause an inflammatory reaction in the body, which may predispose or even directly contribute to atheroma formation in the coronary arteries. In this study, the investigators will study the link between the inflammatory state of the body and will search for a correlation with levels of coronary artery disease and periodontal disease. Inflammatory markers such as high-sensitivity C-reactive protein (hs-CRP), erythrocyte sedimentation rate (ESR), and immunoglobulin G (IgG) levels in the patient's blood will be analyzed and correlated to clinical attachment loss measured via pocket depth measurement, the distance from the gingival margin to the base of the pocket. A definitive link between these disease processes will allow preventive measures to be taken earlier to prevent this lifelong disease.

NCT ID: NCT02981134 Withdrawn - Coronary Disease Clinical Trials

The Usefulness of Coronary CT Scan After Everolimus-eluting Bioabsorbable Scaffold Implantation for Coronary Artery Disease

CT BVS
Start date: December 2021
Phase:
Study type: Observational

The purpose of this study is to evaluate usefulness of coronary computed tomographic scan for prediction of clinical events after everolimus-eluting bioabsorbable scaffold implantation for coronary artery disease.

NCT ID: NCT02932553 Withdrawn - Clinical trials for Angina Pectoris, Variant

BVS Implantation in Patients With Variant Angina and MODerate Coronary Artery Disease

BIVA-pilot
Start date: April 19, 2017
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine whether BVS(Bioresorbable Vascular Scaffold) implantation with optimal medical therapy can improve the outcome of patients with variant angina and moderate coronary artery disease.

NCT ID: NCT02890732 Withdrawn - Coronary Disease Clinical Trials

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

AppET-Coeur
Start date: January 2017
Phase: N/A
Study type: Interventional

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

NCT ID: NCT02735993 Withdrawn - Clinical trials for Coronary Artery Disease

Cardiac REgistry of Celution Device for the Processing of Adipose-derived Regenerative Cells

CREATE
Start date: October 2014
Phase: N/A
Study type: Observational [Patient Registry]

This cardiac registry study will collect information from patients with ischemic or non-ischemic heart failure that have been treated with adipose-derived regenerative cells (ADRCs) delivered via intramyocardial injection.