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Myocardial Ischemia clinical trials

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NCT ID: NCT03712644 Recruiting - Clinical trials for Coronary Artery Disease in Patients With Critical Limb Ischemia

Coronary Revascularization Versus Conservative Therapy in Patients With Treated Critical Limb Ischemia

INCORPORATE
Start date: July 11, 2018
Phase: N/A
Study type: Interventional

The objective of the INCORPORATE trial is to evaluate whether an intentional invasive strategy with ischemia targeted, reasonably complete coronary revascularization and optimal medical therapy is superior as compared to a primary conservative approach and optimal medical therapy alone in terms of spontaneous myocardial infarct-free and overall survival in patients with severe peripheral artery disease, underwent peripheral artery revascularization due to critical limb ischemia. The INCORPORATE trial is designed to be non-blinded, open-label, prospective 1:1 randomized controlled multicentric trial.

NCT ID: NCT03711539 Recruiting - Clinical trials for Coronary Artery Disease

Lifetime Endurance Exercise to Prevent Coronary Artery Disease

MASTER@HEART
Start date: October 18, 2018
Phase:
Study type: Observational

The primary objective of the Master@Heart Trial is to investigate whether lifelong endurance exercise reduces the incidence of non-calcified plaques (both mixed and soft plaques) as compared to late-onset endurance exercise and a non-athletic lifestyle.

NCT ID: NCT03710070 Not yet recruiting - Clinical trials for Coronary Artery Disease

Clinical Efficacy of Permanent Internal Mammary Artery Occlusion in Stable Coronary Artery Disease

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

Cardiovascular diseases remain the number one cause of death globally, primarily consequence of myocardial infarction. Although widely used in stable coronary artery disease (CAD), percutaneous coronary intervention (PCI) has not been shown to reduce the incidence of myocardial infarction or death. In contrast, coronary artery bypass grafting (CABG) significantly reduces rates of death and myocardial infarction compared to PCI, but at a higher rate of stroke. Similarly, coronary collaterals exert a protective effect by providing an alternative source of blood flow to a myocardial territory potentially affected by an acute coronary occlusion. Coronary collaterals represent pre-existing inter-arterial anastomoses and as such are the natural counter-part of surgically created bypasses. Sufficient coronary collaterals have been shown to confer a significant benefit in terms of overall mortality and cardiovascular events. In this regard, the concept of augmenting coronary collateral function as an alternative treatment strategy to alter the course of CAD, as well as to control symptoms, is attractive. While a multitude of interventions has been shown to be effective in collateral growth promotion, so far, the effect of current interventions is only temporary, and therefore, repeated application is necessary to sustain the level of collaterals. The prevalent in vivo function of natural internal mammary arteries (IMA)-to-coronary artery bypasses and their anti-ischemic effect has been recently demonstrated by the investigators' research group. Levels of collateral function and myocardial ischemia were determined in a prospective, open-label clinical trial of permanent IMA device occlusion. In this study, coronary collateral function, has been shown to be augmented in the presence vs the absence of distal permanent ipsilateral IMA occlusion. These findings have been corroborated by the observed reduction in ischemia in the intracoronary ECG. Coronary functional changes observed in response to permanent distal IMA occlusion have so far, not been related to clinical outcome parameters. Therefore, a controlled, randomized, double-blind comparison of clinical efficacy between a group of patients receiving permanent IMA occlusion vs. a sham-procedure will be consequently performed. Since single antianginal agents have been demonstrated to increase exercise time in comparison to placebo, an improvement of the physical performance due to the increased blood flow by the permanent distal IMA occlusion is expected.

NCT ID: NCT03709836 Recruiting - Clinical trials for Coronary Artery Disease

Computed Tomography Angiography Prediction Score for Side Branch Occlusion

CT-PRECISION
Start date: September 25, 2018
Phase:
Study type: Observational

Lesions involving coronary bifurcations account for approximately 20% of all percutaneous coronary interventions (PCI). Revascularization within bifurcation sites remains technically challenging. While the most optimal interventional treatment strategy for bifurcation lesions is still debatable, side branch (SB) occlusion is one of the most serious procedural complications with prevalence rates over 7%. Numerous mechanisms of the SB occlusion (e.g. plaque or carina shift, coronary artery dissection, thromboembolism, coronary artery spasm, etc) have been postulated. Regardless of the cause, loss of the SB is associated with increased risk of periprocedural mortality and myocardial infarction. Therefore, PCI involving coronary bifurcation mandates consideration of the risk of SB compromise. The CT-PRECISION (Computed Tomography angiography PREdiCtIon score for SIde branch Occlusion in coronary bifurcation interventioN) registry was designed to evaluate the application of coronary computed tomography angiography (coronary CTA) for the prediction of SB occlusion during percutaneous revascularization of bifurcation lesions. The main purpose of this single-center study is to develop a noninvasive CTA-based prediction tool to determine the procedural outcome of PCI in bifurcation lesions.

NCT ID: NCT03709693 Not yet recruiting - Clinical trials for Coronary Artery Disease

Clinical Outcomes in Patients Treated With SternaLock Blu

SLRF
Start date: January 1, 2019
Phase:
Study type: Observational [Patient Registry]

The primary objective of this study is to evaluate the rate of deep sternal wound infection at 30 days post-operative following a full median sternotomy in patients treated with SternaLock Blu for rigid sternal fixation. This study will also provide evidence of the clinical performance of SternaLock Blu for up to 90 days using real world evidence methodology. Sternal complications will be reported through 90 days follow up.

NCT ID: NCT03707626 Recruiting - Clinical trials for Coronary Artery Disease

Collateral Circulation to LAD and Wellens Sign

Start date: September 26, 2018
Phase:
Study type: Observational

Overall Aim Coronary artery disease significantly contributes to morbidity and mortality in the United States. Atherosclerotic disease can lead to stenosis of the coronary arteries and subsequent cardiac hypoperfusion. Patients with a critical stenosis of the LAD, potentially leading to acute anterior wall myocardial infarction, may be asymptomatic at presentation with subtle EKG changes as its only manifestation. It is imperative for physicians to recognize patients with new T wave inversions in leads V2-V3 as the standard course of management may lead to poor prognosis. The purpose of this study is to determine if collateral circulation to the left anterior descending (LAD) artery will mask the presence of a Wellens sign and therefore diminish its diagnostic utility. The conclusion of this study would raise awareness for physicians in light of an absent Wellens sign. Hypothesis The presence of coronary collateral circulation to the LAD masks the presence of a Wellens sign (both Type 1 and Type 2) in precordial leads V2-V4.

NCT ID: NCT03703349 Not yet recruiting - Clinical trials for Coronary Artery Disease

Preoperative Oral Magnesium to Prevent Postoperative Atrial Fibrillation Following Coronary Surgery (POMAF-CS)

POMAF-CS
Start date: October 2018
Phase: Phase 4
Study type: Interventional

Post operative atrial fibrillation following coronary surgery (POAF) is a common complication that can affect 10-50% of patients. Intravenous magnesium, administered per-or post-operatively, reduces the incidence of POAF. However, the effect of preoperative magnesium loading on the incidence of POAF is not yet studied. 200 patients admitted for elective coronary surgery under Cardiopulmonary bypass will be included in this prospective randomized controlled trial. Treatment group will receive preoperative oral magnesium and control group will receive placebo for 3 days before the planned coronary artery surgery. The occurrence of POAF will be studied as a main outcome.

NCT ID: NCT03702244 Not yet recruiting - Clinical trials for Coronary Artery Disease

The PRECISE Protocol: Prospective Randomized Trial of the Optimal Evaluation of Cardiac Symptoms and Revascularization

PRECISE
Start date: October 29, 2018
Phase: N/A
Study type: Interventional

The study will be a prospective, pragmatic, randomized clinical trial of the comparative effectiveness of diagnostic evaluation strategies for stable CAD, to be performed in outpatient settings, including primary care and cardiology practices.

NCT ID: NCT03700645 Not yet recruiting - Diabetes Mellitus Clinical Trials

Allopurinol in Diabetes Mellitus and Multivessel Coronary Artery Disease

Start date: October 1, 2018
Phase: Phase 4
Study type: Interventional

Atherosclerosis is a progressive disease of the arterial wall, arising from the combination of endothelial dysfunction and inflammation. This link is exacerbated in diabetic patients. Uric acid is known to generate oxidative stress and it's elevated levels has been shown to be associated with cardiac hypertrophy, inflammation, myocardial fibrosis and diastolic dysfunction. Allopurinol inhibits xanthine oxidase, an enzyme that regulates uric acid production. In observational studies it has been shown to reduce ischemia, inflammation and improve coronary flow. The aim of this study is to see whether treatment with Allopurinol in patients diagnosed with multivessel disease and undergoing treatment with either percutaneous coronary intervention (PCI) or coronary artery bypass surgery (CABG) , will reduce markers of inflammation and improve quality of life and major adverse cardiovascular effects (MACE).

NCT ID: NCT03696446 Not yet recruiting - Clinical trials for Coronary Heart Disease

E-health Intervention for Cardiac Rehabilitation

VCRP-RCT
Start date: October 15, 2018
Phase: N/A
Study type: Interventional

Cardiac rehabilitation (CR) is designed to increase healthy behaviours (e.g. physical activity, healthy eating, smoking abstinence) and reduce risk factors (e.g. high blood pressure & cholesterol) in order to improve quality of life and health among people with heart disease. Unfortunately, few patients attend CR, often reporting several barriers to access including travel distance, parking fees and lack of time. Advances in technology have the potential to improve accessibility and delivery of CR programs, and improve patient empowerment. The University of Ottawa Heart Institute has developed an e-health program called the Virtual Cardiac Rehabilitation Program (VCRP); an online cardiovascular health management system (website & Smartphone app) that provides strategies for the control and management of risk factors. The goals of VCRP are to: empower and educate patients; foster better communication between patients and their health care team; stimulate shared decision making; and, facilitate care coordination leading to better health outcomes. The VCRP provides patients with: real-time access to their health information, as well as tracking of risk behaviours and factors through integration with devices; a wellness plan; access to a personal on-line health coach; goal-setting notifications; on-line community forums; and, circle of care access to information. The aim of this project is to evaluate the effects of VCRP (with integrated fitness tracker) compared to a standard, home-based CR program. The study will look at changes in: patient empowerment; health behaviours; risk factors; quality of life; clinical outcomes; and, costs. The study will improve our understanding of: patient and provider needs; program usability; and shared decision-making. Results will inform the use of e-health programs such as VCRP into healthcare settings to improve patient empowerment, shared decision-making, and the ability to integrate wearable monitors to improve health behaviours.