Brain Circuitry Changes in Vascular Parkinsonism Save

Date Added
July 6th, 2017
PRO Number
Pro00063429
Researcher
Christine Cooper
Keywords
Parkinsons, Vascular
Summary

This study will examine changes in brain architecture that are associated with vascular parkinsonism, in comparison to Parkinson's disease. We will do this by using advanced imaging techniques to compare brain structure between subjects with vascular parkinsonism and Parkinson's disease.

Institution
MUSC
Recruitment Contact
Nancy Feracco
843-792-7859
feracco@musc.edu

Actelion Protocol AC-055-205: A Prospective, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety of Macitentan in Patients with Pulmonary Hypertension After Left Ventricular Assist Device Implantation Save

Date Added
August 5th, 2016
PRO Number
Pro00053983
Researcher
Patrick Mccann
Keywords
Cardiovascular, Drug Studies, Heart, Pulmonary Arterial Hypertension (PAH), Vascular
Summary

The Actelion SOPRANO study is a prospective, multicenter, double-blind, randomized, placebo-controlled, parallel-group Phase II study to evaluate the safety and effect of macitentan on pulmonary vascular resistance in subjects with pulmonary hypertension after left ventricular assist device (LVAD) implantation. Male and female patients 18 years of age or older who have had surgical implantation of LVAD may be eligible to participate in this study.

Study Site:
Palmetto Heart
8 Richland Medical Park
Columbia, SC 29203

Study Site Principal Investigator Contact Information:
Patrick McCann, MD at 803-434-3800

Institution
Palmetto
Recruitment Contact
Patrick McCann
803-434-3800
ClinicalTrialSurvey@PalmettoHealth.org

ASSESSMENT OF THE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS IN THE TREATMENT OF ABDOMINAL AORTIC ANEURYSMS Save

Date Added
October 27th, 2015
PRO Number
Pro00047297
Researcher
Ravi Veeraswamy
Keywords
Surgery, Vascular
Summary

This study is being conduct to assess the safety and effectiveness of a Study Sevice,GORE® EXCLUDER® Conformable AAA Endoprosthesis, in patient's with an aneurysm in their abdominal aorta. In this research study, the Study Device will be placed inside the abdominal aorta (in the approximate area of the belly button) and the Study Device will extend into both leg arteries. The Study Device will block the aneurysm (the weakened and bulging part of the artery) in the abdominal aorta from blood flow while maintaining blood flow to the arteries in the legs. Information will be collected on the performance of the Study Device for up to five (5) years.

Institution
MUSC
Recruitment Contact
Corie Lynn
843-792-8874
lynnc@musc.edu

PeRiodontal treatment to Eliminate Minority InEquality and Rural disparities in Stroke Save

Date Added
July 21st, 2015
PRO Number
Pro00044329
Researcher
Souvik Sen
Keywords
Periodontal Disease, Stroke, Vascular
Summary

The PREMIERS study is a proposal for conducting an adequately powered two center phase III randomized controlled trial to test whether intensive periodontal treatment reduces the risk of recurrent vascular events among ischemic stroke and TIA survivors. The study uses the resources in both states including established
dental centers, Joint Commission Certified Stroke Centers, the Schools of Public Health, and the Institute for Partnerships to Eliminate Health Disparities. The proposal addresses specific issues with regards to recruitment of African-American and rural stroke/TIA patients advocating the use of culturally appropriate strategies to educate the study subjects regarding stroke, periodontal disease and the periodontal stroke link.
The study proposes to utilize economic evaluation of the periodontal intervention from the budgetary
perspective. The focus will be on the financial sustainability of providing aggressive periodontal therapy (with
certain, although relatively low expenditures) in exchange for a reduction of uncertain recurrent vascular events
that may require high cost emergency department utilization and/or inpatient care. The sustainability of the
proposed intervention after the completion of the project is integrally linked to the health economic assessment
to show the health care cost savings. By integration with a rural primary care center, with an African American
majority and households with average incomes below the state average, the study ensures that the proposed
intervention to reduce stroke disparity is applicable to this target population.

Institution
Palmetto
Recruitment Contact
Lauren Giamberardino
8035456078
lauren.dennis@uscmed.sc.du

Monitoring and Managing Newly Healed Chronic Leg and Foot Ulcer Skin Temperature: A Cooling Intervention (MUSTCOOL) to Prevent Ulcer Recurrence Save

Date Added
June 2nd, 2015
PRO Number
Pro00043450
Researcher
Teresa Kelechi
Keywords
Aging, Circulation, Diabetes, Inflammation, Skin, Vascular
Summary

Individuals with venous leg and diabetic foot ulcers often find these ulcers take a long time to heal and when they do, sometimes they come back. These ulcers can be quite painful making it hard to work, sleep and go about one's day to day activities. You will be asked to do a self-care routine of taking the temperature of the skin where the leg or foot ulcer just healed with a special thermometer and applying a small cooling gel patch over this skin. We want to know if this routine will prevent the ulcer from coming back, help you to become more active, and improve the quality of your life.

Institution
MUSC
Recruitment Contact
Margaret Prentice
843 792 4771
prenticm@musc.edu

FOOTFIT Mhealth Physical Activity Intervention for Leg Ulcer Patients Save

Date Added
May 5th, 2015
PRO Number
Pro00043451
Researcher
Teresa Kelechi
Keywords
Aging, Circulation, Exercise, Skin, Vascular
Summary

This study will test a low intensity foot exercise program for people with lower leg ulcers and who have problems with walking to see if it improves the condition of the legs. A small activity monitoring tracker called an accelerometer will be placed on the foot during the exercises that are to be done in the home for about 6 weeks. The tracker sends movement information to a cell phone that lets you and your doctor know about improvements in the foot movements. Better foot movements help condition the muscles and joints and may improve activity such as walking and getting up from a chair.

Institution
MUSC
Recruitment Contact
Darla Howard
864-560-1042
dhoward@srhs.com

A Post Market Observational Study on the Use of Cormatrix ECM for Femoral Arterial Reconstruction (PERFORM Study) Save

Date Added
April 21st, 2015
PRO Number
Pro00041950
Researcher
Thomas Brothers
Keywords
Surgery, Vascular
Summary

The purpose of this study is to gather additional information on the use of CorMatrix ECM (Extracellular Matrix) for use in a standard femoral artery reconstruction procedure.This naturally occurring extracellular matrix biomaterial supports native tissue repair by providing an interim bioscaffold, that enables a patient's own cells to repopulate and repair damaged tissues.

Institution
MUSC
Recruitment Contact
Corie Lynn
843-792-8874
lynnc@musc.edu

Pro00039871; COMPASS Pilot: Comparative Effectiveness of Treatment Options Using Propensity Score Methods in Cervical Artery Dissection Save

Date Added
December 30th, 2014
PRO Number
Pro00039871
Researcher
Souvik Sen
Keywords
Brain, Stroke, Vascular
Summary

Design and Procedures
The objective of this research proposal is to compare treatment strategies currently being used to treat an uncommon condition, symptomatic CAD, by conducting a prospective longitudinal observational study using a patient-centered web-based data capture. We will conduct several comparative research protocols prioritized by CAD survivor focus groups and surveys. The prospective component of COMPASS Pilot will utilize both the i2b2 and RFA database combined with additional follow up interviews of 100 CAD survivors at 6 months and 12 months after discharge, for a combined cohort to obtain detailed information on patient ?reported outcomes.

The proposed project will use a cohort study design (N=100) with web-based data capture to acquire high quality information. Detailed observational data will be collected and used in propensity score analysis to adjust for the baseline differences in treatment groups. This includes differences arising from selection bias and measured confounders. The propensity score based adjustment of these differences will result in a better estimate of the effect size. A user friendly, web-based data capture tool will facilitate the identification of clinically significant outcomes in a larger number of patients. Once validated, the methodology can be used to obtain evidence of comparative effectiveness that will aid decision-making in treatment of other rare neurological diseases where RCTs are unfeasible.

Study Outcomes
The following are candidate outcomes of interest in COMPASS Pilot for both therapeutic areas:
? ?Home-time? (days alive and at home)
? Death
? Stroke/TIA readmission
? All-cause readmission
? Cardiovascular readmission
? Bleeding readmission

Subject Selection
The COMPASS Pilot study plans on inclusion of a diverse study population with respect to age, gender, race, ethnicity, geography, or clinical status. Specific patient selection criteria:

Inclusion Criteria
1. Patients who are at least 18 years of age.
2. Extracranial carotid or vertebral artery dissection with symptom onset within the last ninety days. Patients will be included with ipsilateral TIA or stroke and ipsilateral Horner?s syndrome or neck pain with known onset.
3. Imaging evidence of definite or probable dissection on magnetic resonance imaging (MRI)/magnetic resonance angiography (MRA), computed tomography angiography (CTA) or ultrasound (patients can be initially randomized on ultrasound alone but subsequent MR or CTA confirmation is needed).
4. Patient or patient?s legally appointed representative has been informed of the nature of the study, agrees to participation, and has signed an IRB approved consent form.

Exclusion Criteria
1. Symptom onset more than ninety days
3. Contraindications to either antiplatelet agents or anticoagulation therapy
4. Patient refusal to consent
5. Patient unable to follow-up for the 12 month period.

Institution
Palmetto
Recruitment Contact
Souvik Sen
803-545-6078
souvik.sen@uscmed.sc.edu

Pro00040053; CAPS 2 Pilot: Change in Antiplatelet Therapy in Prevention of Secondary Stroke Save

Date Added
December 30th, 2014
PRO Number
Pro00040053
Researcher
Souvik Sen
Keywords
Brain, Stroke, Vascular
Summary

Design and Procedures
The objective of this research proposal is to compare antiplatelet agents currently being used to prevent recurrent vascular event in stroke/TIA patients already on an Aspirin prior to their index stroke/TIA, by conducting a prospective longitudinal hybrid cohort study using a patient-centered web-based data capture and analysis strategies that adjust for confounders. This will be accomplished by designing and implementing a viable alternative strategy to a RCT to assess the comparative effectiveness of treatment strategies, when an RCT is not feasible. The comparisons to be evaluated include three types of antiplatelet agent changes:
1) Aspirin ? Aspirin
2) Aspirin ? Clopidogrel
3) Aspirin ? Aspirin+Extended Release Dipyridamole
The prospective component of CAPS2 Pilot will utilize both the i2b2 and RFA database combined with additional follow up interviews of 300 Stroke/TIA survivors at 6 months and 12 months after discharge, for a combined cohort to obtain detailed information on patient ?reported outcomes.

The proposed project will use a cohort study design (N=300) with web-based data capture to acquire high quality information. Detailed observational data will be collected and used in propensity score analysis to adjust for the baseline differences in treatment groups. This includes differences arising from selection bias and measured confounders. The propensity score based adjustment of these differences will result in a better estimate of the effect size. A user friendly, web-based data capture tool will facilitate the identification of clinically significant outcomes in a larger number of patients. Once validated, the methodology can be used to obtain evidence of comparative effectiveness that will aid decision-making in treatment of other rare neurological diseases where RCTs are unfeasible.

Study Outcomes
The following are candidate outcomes of interest in CAPS2 Pilot:
? Primary Outcomes ? composite of stroke, death, and myocardial infarction
? Secondary Outcomes ? patient related outcome measures: pain, adherence, disability, and side effects

Subject Selection
The CAPS study plans on inclusion of a diverse study population with respect to age, gender, race, ethnicity, geography, or clinical status. Specific patient selection criteria:

Inclusion Criteria
1. Patients who are at least 18 years of age.
2. TIA ?30 days with ABCD2 score of ?4.
3. Ischemic stroke ?30 days confirmed by imaging (MRI or CT scan).
4. Patient on daily antiplatelet therapy with Aspirin ?30 days prior to index stroke/TIA and prescribed Aspirin,
Clopidogrel or Aspirin with extended release Dipyridamole by his/her physician.
5. Patient or patient?s legally appointed representative has been informed of the nature of the study, agrees to participation, and has signed an IRB approved consent form.

Exclusion Criteria
1. Patient or legally authorized representative (LAR) unable to give informed consent
2. Patients presenting with primary hemorrhagic stroke (intracerebral or subarachnoid hemorrhage)
3. Patients on oral anticoagulation therapy
4. Patient unable to take medications by mouth
5. Patient unable to follow-up for the 12 month period.
6. Participation in another stroke prevention randomized clinical trial

Institution
Palmetto
Recruitment Contact
Souvik Sen
803-545-6078
souvik.sen@uscmed.sc.edu

Pro00037528; Prospective Multi-Center Evaluation of the Duration of Therapy for Thrombosis in Children (the ?Kids-DOTT? Trial) Save

Date Added
December 23rd, 2014
PRO Number
Pro00037528
Researcher
Stuart Cramer
Keywords
Blood Disorders, Vascular
Summary

The Kids-DOTT trial is a randomized controlled clinical trial whose primary objective is to evaluate non-inferiority of shortened-duration (6 weeks) versus conventional-duration (3 months) anticoagulation in children with first-episode acute venous thrombosis. The first stage of the trial has consisted of a pilot/feasibility component, which then continues as the definitively-powered trial.

Male and female patients who meet the following criteria may take part in this study:

Inclusion Criteria:
1. Children (birth to less than 21 years of age) with radiologically-confirmed acute venous thrombosis in the past 30 days
2. In the opinion of the investigator, the venous thrombosis was a provoked (i.e., non-spontaneous) event (e.g.: hospitalization; Central venous catheterization; infection; dehydration; surgery; trauma; immobility; use of estrogen-containing oral contraceptive pills; flare of autoimmune/rheumatologic condition).

Exclusion Criteria:
1. Prior episode of venous thromboembolism (VTE)
2. Presence or history of cancer
3. Systemic lupus erythematosus
4. Known pulmonary embolism (PE), except when limited to peripheral cavitary lesions representing septic emboli; (N.B. imaging for PE should only have been based upon clinical signs/symptoms, and is not a study procedure or requirement)
5. Use of, or intent to use, thrombolytic therapy
6. Patients with congenital cardiac disease involving a single or hypoplastic ventricle or otherwise requiring an intracardiac shunt
7. Moderate/severe anticoagulant deficiency as defined by any one of the following:
a. protein C less than 20 IU/dL if patient is greater than or equal to 3 months of age, or protein C below lower limit of detection if patient is less than 3 months of age;
b. antithrombin less than 30 IU/dL if patient is greater than or equal to 3 months of age, or antithrombin below lower limit of detection if patient is less than 3 months of age;
c. protein S (free antigen or activity) less than 20 IU/dL.

Study Site:
Children?s Center for Cancer & Blood Disorders / Palmetto Health Children?s Hospital
7 Richland Medical Park
Columbia, SC 29203

Study Site Principal Investigator Contact Information:
Stuart L. Cramer, DO at 803-434-3533

Institution
Palmetto
Recruitment Contact
James French
803-434-3533
Selena.Lollar@PalmettoHealth.org

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