View clinical trials related to Angina.
Filter by:Coronary disease is one of the most frequent pathology of the modern world and the leading cause of death in the investigators country. In Spain more than 50.000 coronary percutaneous intervention and more than 5.000 coronary artery bypass graft (CABG) procedures are performed every year. Despite this data about 12% of patients have diffuse coronary disease and are not candidates to conventional therapies. Also between 15-25% of patients undergoing coronary bypass grafting receive an incomplete revascularization due to the poor quality of the coronary vessels. Transmyocardial revascularization (TMR) is a surgical procedure that uses a laser to create channels through the myocardial, so this laser stimulates local angiogenesis and provides blood in the ischemic area. Results of this procedure have shown clear benefits in terms of reduction of angina and increase of survival of patients, compared to medical treatment. Cell therapy in heart disease is offering in recent years encouraging results despite the methodological difficulties that being able to use this technique sometimes involves. The basis lies in the potential ability of stem cells to differentiate into any type of adult cell. In the case of cardiac cell therapy, stem cells can differentiate into myocardial cells or vascular cells capable of developing angiogenesis. Further studies are needed to draw firm conclusions about the clinical impact that the use of stem cells has on cardiovascular disease. Recently a system has been developed to create, at the same time and in a simple and effective way, the laser channels and the introduction of stem cells on the edges of these channels. This system called PHOENIX ™ consists of a laser probe capable of creating transmural channels in the myocardium. Based on the what has just been explained, it is quite possible that the combination of both therapies can increase successful results regarding the reduction in angina these patients need. Initially, and after having some experience with this type of treatment, the results could be analyzed and compared with the results obtained through laser therapy, with the help of a controlled clinical trial, such as the one the investigators are proposing.
The current outpatient evaluation for angina in low and intermediate risk patients typically starts with a functional assessment for coronary ischemia. Exercise treadmill testing is often selected as the initial diagnostic modality for coronary artery function. However, exercise treadmill testing is limited by its moderate sensitivity and specificity, often resulting in further cardiac resource utilization for patient risk stratification and reassurance. With the advent of coronary multislice computed tomography (MSCT) angiography, coronary artery anatomy can now be evaluated noninvasively. Despite its impressive performance characteristics, the role of coronary MSCT angiography in the outpatient evaluation of angina remains undefined. CT-EXTRA compares the impact on patient safety and downstream resource utilization of a novel initial diagnostic strategy employing the addition of coronary MSCT angiography to exercise treadmill testing with a standard diagnostic strategy of exercise treadmill testing for the ambulatory evaluation of low-intermediate risk patients with possible angina. The study is a single center, prospective, non-blinded, randomized clinical trial. Men and women, age 18-70, with a low to intermediate pretest probability of coronary artery disease who are referred for an exercise treadmill test for angina are eligible. Subjects are randomized either to an initial diagnostic strategy of exercise treadmill testing or exercise treadmill testing with coronary MSCT angiography. Subsequent diagnostic testing and treatment are the discretion of the referring physician. Subjects will be clinically followed for 24 months. The clinical impact on patient safety and downstream clinical resource utilization of this novel diagnostic strategy in which both coronary artery anatomy and function are initially evaluated will be determined. The primary outcome is a composite endpoint consisting of freedom from adverse cardiac events, further cardiac diagnostic testing, and future cardiac clinical encounters. Secondary outcomes include the impact on the indiscriminate use of coronary angiography, subject anxiety, depression, motivation for healthy behavioral change, and satisfaction with diagnostic evaluation and use of antiplatelet and antilipid therapy. Lastly, the cost effectiveness of the routine addition of coronary MSCT angiography in the outpatient evaluation of possible angina will be determined.