Clinical Trials

5 studies in Coronary Artery Disease

1. An Observational Study of Cholesterol in Coronary Arteries Rochester, MN View Summary
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   An Observational Study of Cholesterol in Coronary Arteries

   Location:

   Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   In April 2008, a coronary catheter based imaging system, LipiScan, was cleared by the FDA for use in detecting lipid core containing containing plaques of interest (LCP). These plaques are rich in cholesterol. The way that cholesterol and other lipids deposit with the coronary artery is unique to each patient. This study is an organized attempt to observe the LCP and the variety of ways that it presents in patients as detected by this recently approved device. This information will be used for physician training and to observe the behavior of the LCP in response to no therapy and currently approved therapies. The purpose of this project is further medical knowledge of the LCP and its treatment.

   NCT ID:

   NCT00831116

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   Who can I contact for additional information about this study?

   Rochester: Cindy M Woltman, RN 507-266-4095
                       
   
   
   

2. Exercise Stress Testing on Peripheral Gene Expression Using CORUS™ CAD Diagnostic Test Jacksonville, FL View Summary
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   Exercise Stress Testing on Peripheral Gene Expression Using CORUS™ CAD Diagnostic Test

   Location:

   Jacksonville, FL

   Trial status:

   Open for Enrollment

   Why is this study being done?

   Pilot study, investigates the effects of "acute" exercise on PGE levels as measured by CORUS CAD score.

   NCT ID:

   NCT01486030

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   Who can I contact for additional information about this study?

   
   
   Jacksonville: Gerald Fletcher, MD
                       Barbara Little, RN
   

3. Assessment of Cardiac Allograft Vasculopathy With Optical Coherence Tomography Rochester, MN View Summary
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   Assessment of Cardiac Allograft Vasculopathy With Optical Coherence Tomography

   Location:

   Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   Cardiac allograft vasculopathy (CAV) is a progressive disease of the coronary arteries in transplanted hearts which is a significant cause of morbidity and mortality. The broad objective of this research study is to advance our ability to diagnose as early as possible the presence of CAV and to non-invasively predict those patients at increased risk of CAV with novel techniques. Optical coherence tomography (OCT) is a novel intracoronary imaging technique using an optical analog of ultrasound with a resolution 10 times greater resolution than intravascular ultrasound (IVUS). Endothelial progenitor cells (EPCs) in peripheral blood have been shown to play a role in the pathogenesis of atherosclerosis and peripheral arterial tonometry is a clinical tool used to predict endothelial dysfunction (a precursor of atherosclerosis) which has been validated in non-transplant patients. Patients scheduled for routine cardiac catheterization with IVUS at the Mayo Clinic Rochester, MN that reach inclusion and exclusion criteria for the study will be approached on the day to get informed consent to perform OCT, blood sampling and peripheral endothelial function testing. The investigators aim to 1) compare the frequency and plaque type of CAV as defined with OCT versus IVUS-Virtual Histology (IVUS-VH), 2) predict the presence and severity of CAV with absolute counts of EPCs and 3) with peripheral endothelial function scores.

   NCT ID:

   NCT01527344

   IRB Number:

   11-003775

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   Who can I contact for additional information about this study?

   Rochester: Jasmine A Sexton 507-288-4665
                       
   
   
   

4. Regadenoson Real Time Perfusion Imaging Trial-Optison Rochester, MN View Summary
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   Regadenoson Real Time Perfusion Imaging Trial-Optison

   Location:

   Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   Stress perfusion imaging has primarily been done with radionuclide scintigraphy or single photon emission computed tomography (SPECT) and has not reached its full clinical potential because of the poor spatial resolution of SPECT, increased expense of this procedure, patient exposure to ionizing radiation, and lack of availability. The A2A receptor agonist Regadenoson has been utilized to detect myocardial perfusion abnormalities during SPECT myocardial perfusion imaging. A 100 patient pilot study (Regadenoson Real Time Perfusion Imaging Trial, IRB #566-08-FB) demonstrated the feasibility and accuracy of real-time perfusion echocardiography (RTPE) in detecting coronary artery disease following Regadenoson bolus injection and Definity as an ultrasound contrast agent. The aim of this study is to determine whether similar feasibility and accuracy can be achieved with Optison (a Food and Drug Administration approved ultrasound contrast agent that differs slightly in microbubble size and composition) in detecting coronary artery disease (CAD) following Regadenoson bolus injection. As with the original study, sensitivity, specificity, and accuracy of perfusion and wall motion analysis to identify a coronary stenosis >50% in diameter by quantitative angiography will be analyzed.

   NCT ID:

   NCT01489176

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   Who can I contact for additional information about this study?

   - Mayo Clinic Cancer Center - Phone: 507-538-7623 - Research Volunteer Program - Phone: 1-800-664-4542 (toll-free) Email: clinicaltrials@mayo.edu - International Research - Phone: 507-284-8884 Email: intl.mcr@mayo.edu

5. Exercise and Low-Dose Rapamycin in Older Adults With CAD:Cardiac Rehabilitation And Rapamycin in Elderly (CARE) Trial Rochester, MN View Summary
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   Exercise and Low-Dose Rapamycin in Older Adults With CAD:Cardiac Rehabilitation And Rapamycin in Elderly (CARE) Trial

   Location:

   Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   Participants: Pilot study: Patients, 70 years or older, selected for this single-center open label pilot study will be consented for participation at initiation of CR following PCI or CABG. We will enroll up to 18 patients; no more than 6 patients will receive a dose at one of the three proposed levels:0.5mg, 1.0mg, and 2mg daily oral rapamycin for the duration of CR (typically 12 weeks). We will perform physical performance tests for frailty assessment, short-form 12 for quality of life, and tests for SASP [(IL-6), matrix metalloproteinase (MMP) 3, and monocyte chemotactic protein (MCP) 1], and abdominal/thigh subcutaneous adipose biopsy for measurement of adipocyte mitochondrial DNA copy number and to quantitate the number of senescent preadipocytes. at baseline and at the conclusion of CR. Fasting lipid panel will be performed at baseline and at the completion of CR. Baseline complete blood count, liver, and kidney functions will be performed. These tests will be repeated at 14 days, 30 days, 8 weeks, and at the completion of CR. Serum rapamycin levels will be measured at 7, 14, 30 days, and at the completion of CR. The serum levels of the drug will be kept below 6ng/ml. If the drug levels were found to be higher, next low dose of the medication will be prescribed. Participants with serious side effects (appendix) from the medications will be withdrawn from the study. Patients will be enrolled in sets of three. Thirty days of monitoring must pass on all three subjects before three more may be enrolled. The first three patients will be assigned to the 0.5 mg dose level. If two patients of those three have serious adverse events, the pilot study will be terminated. If 1 of 3 patients has an serious adverse event, we will enroll three more subjects at the 0.5 mg level. If those three have no serious events or if there were no events in the first three subjects, then we will proceed to enroll three subjects at the 1.0mg level. Otherwise, if there are 2 or more serious events in the 6 patients assigned to 0.5mg, we will terminate the study. We will proceed similarly with the 1.0 mg level before enrolling patients to the 2.0 mg level. If we observe 2 serious events at the 1.0 mg level and only 3 patients have been enrolled at the 0.5mg level, we will finish the pilot by enrolling 3 more at the 0.5 mg level. Similarly, if we observe 2 serious events at the 2.0 mg level and only have 3 subjects (with 0 events) at the 1.0 level, we will enroll 3 more at the 1.0 level. Randomized Trial: The Cardiac rehabilitation And Rapamycin in Elderly (CARE) study is a prospective, randomized, phase 2 clinical trial that will be done at Mayo Clinic, Rochester, MN. The pool of potential study participants will consist of all patients 70 years or older with CAD who are referred to the CR following PCI or CABG. To minimize the drop out rate, we will obtain consent at the end of first week of CR participation, since most patients who quit CR do so in the first week. Consent will be obtained by the study coordinator. Baseline Assessment: Following informed consent, assessments of height, weight, and blood pressure will be made, and all participants will have a chemistry 15 panel, complete blood cell count, and an electrocardiogram. Race and ethnicity will be self-reported. Baseline demographic, angiographic, and other relevant clinical and laboratory data will be entered prospectively into a database. Biochemical parameters: The mechanisms through which rapamycin retard cellular senescence and extend life span are still unclear. With this aim, a better understanding of effects of rapamycin on inflammation, mitochondrial DNA copy number, quantitation of senescent preadipocytes and diverse biomarkers of aging could be demonstrated. To assess the effect of CR, we will assess these parameters at baseline and then at the completion of the CR program. SASP: Proinflammatory biomarkers, IL-6, MMP 3 and MCP 1 will be studied (ELISA). Patients will be randomized in a 1:1 ratio to either regular CR, or CR with the addition of 0.5mg/1.0mg/2.0mg of rapamycin. The lowest dose of rapamycin that demonstrates potential to reduce SASP, and/or improve AAI in the pilot trial will be used. Inclusion Criteria 1. Age 70 years or older 2. Post-revascularization patients being enrolled in CR. 3. Informed written consent. Exclusion criteria 1. Class III or IV CHF. 2. Creatinine > 2.0 mg/dl. 3. HbA1c > 13%. 4. Any malignancy 5. Hematological disorder, including thrombocytopenia, leucopenia. 6. Noncardiac illness expected to limit survival. 7. Chronic liver disease. 8. Suspected or known pregnancy. 9. Geographically inaccessible or unable to return for follow-up. 10. Unable to understand or cooperate with protocol requirements. 12. Post organ transplant or with immune-compromised status 13. Prior stroke with disability, severe Parkinson disease 14. Dementia 15. Post-CABG <3 months or any evidence of active wounds or ulcers. 16.Anticipating elective surgery in the 3 months following enrollment.

   NCT ID:

   NCT01649960

   IRB Number:

   11-007896

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   Who can I contact for additional information about this study?

   Rochester: Mandeep Singh, MD