مراكز الأوعية الدموية

بالأسفل التجارب السريرية الحالية.

غربل قائمة الدراسات هذه بالموقع والحالة وغيرها.

1. A Study to Evaluate Advanced Ultrasound Techniques for Diagnosis of Giant Cell Arteritis

   Rochester, Minn.

   The purpose of this study is to find out if advanced ultrasound studies can be used to make a diagnosis of giant cell arteritis. Ultimately, we hope to be able to offer non-invasive diagnostic options as an alternative to biopsy to future patients who are being evaluated for giant cell arteritis.

    

2. A Study of Atrial Cardiopathy and Antithrombotic Drugs In Prevention After Cryptogenic Stroke

   Jacksonville, Fla.

   The primary purpose of this study is to test the theory that Eliquis (apixaban) is superior to aspirin for the prevention of recurrent stroke in patients with cryptogenic ischemic stroke and atrial cardiopathy.

3. Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial - Hemodynamics (CREST-H)

   Rochester, Minn., Jacksonville, Fla.

   We aim to determine whether cognitive impairment attributable to cerebral hemodynamic impairment in patients with high-grade asymptomatic carotid artery stenosis is reversible with restoration of flow. To accomplish this aim CREST-H will add on to the NINDS-sponsored CREST-2 trial (parallel, outcome-blinded Phase 3 clinical trials for patients with asymptomatic high-grade carotid artery stenosis which will compare carotid endarterectomy plus intensive medical management (IMM) versus IMM alone (n=1,240), and carotid artery stenting plus IMM versus IMM alone (n=1,240) to prevent stroke and death). CREST-H addresses the intriguing question of whether cognitive impairment can be reversed when it arises from abnormal cerebral hemodynamic perfusion in a hemodynamically impaired subset of the CREST-2 -randomized patients. We will enroll 500 patients from CREST-2, all of whom receive cognitive assessments at baseline and yearly thereafter. We anticipate identifying 100 patients with hemodynamic impairment as measured by an inter-hemispheral MRI perfusion "time to peak" (TTP) delay on the side of stenosis. Among those who are found to be hemodynamically impaired and have baseline cognitive impairment, the cognitive batteries at baseline and at 1 year will determine if those with flow failure who are randomized to a revascularization arm in CREST-2 will have better cognitive outcomes than those in the medical-only arm compared with this treatment difference for those who have no flow failure. We hypothesize that hemodynamically significant "asymptomatic" carotid disease may represent one of the few examples of treatable causes of cognitive impairment. If cognitive decline can be reversed in these patients, then we will have established a new indication for carotid revascularization independent of the risk of recurrent stroke.

4. International Bicuspid Aortic Valve Consortium (BAVCon)

   Rochester, Minn.

   Bicuspid aortic valve (BAV) disease is the most frequent congenital cardiac malformation, occurring in 0.5-1.2% of the US population. In young adults, it is generally a benign abnormality; but in older adults it is associated with thoracic aortic aneurysm or dissection in 20-30% of those with BAV. BAV is strongly associated with early development of aortic valve calcification or incompetence in >50% of BAV patients, and accounts for ~40% of the >30,000 aortic valve replacements (AVR) performed in the US each year. Yet, we know little of the etiology, cellular events and modifiers of progression of BAV to calcific aortic valve disease and we still do not understand the genetic cause(s) of BAV despite evidence for its high heritability.

   The Specific Aims of this study are:

   1. To identify the genetic causes of bicuspid aortic valve disease and its associated thoracic aortic disease.

   2. To identify potential pathways to predict the clinical course of BAV disease and for treating human BAV disease.

   To achieve these aims, we have created the International Bicuspid Aortic Valve Consortium (BAVCon), a consortium of institutions with cohorts of BAV patients and the expertise to fulfill the performance of these aims.

5. Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial

   Rochester, Minn., Jacksonville, Fla.

   Carotid revascularization for primary prevention of stroke (CREST-2) is two independent multicenter, randomized controlled trials of carotid revascularization and intensive medical management versus medical management alone in patients with asymptomatic high-grade carotid stenosis. One trial will randomize patients in a 1:1 ratio to endarterectomy versus no endarterectomy and another will randomize patients in a 1:1 ratio to carotid stenting with embolic protection versus no stenting. Medical management will be uniform for all randomized treatment groups and will be centrally directed.

6. The Assessment of Prednisone In Remission Trial - Centers of Excellence Approach

   Rochester, Minn.

   This study is a multi-center randomized controlled trial to evaluate the effects of using low-dose prednisone as compared to stopping prednisone treatment entirely. Participants will be randomized 1:1 to taper their prednisone dose down to 5 mg/day or to 0 mg/day for the duration of the study (approximately six months) or until a study endpoint.

7. Low Dose Naltrexone to Improve Physical Health in Patients With Vasculitis

   Rochester, Minn.

   The purpose of this clinical trial is to determine if low dose naltrexone is effective in improving health-related quality of life (HRQoL) among patients with vasculitis. Although it is a pilot study, a placebo-controlled component is used because of the prominent placebo group effect seen in studies with self-reported subjective outcomes.

   Naltrexone is an FDA approved drug (for alcoholism) that has found widespread use "off-label" to treat pain and improve quality of life at much lower doses than are used for the approved indication. There are a few scientific studies in three conditions (fibromyalgia, Crohn's disease, and multiple sclerosis) that suggest that this drug has benefit and is safe. However, considering the extent of use in other conditions, and uncertainty about the mechanism of action study is needed in a diverse set of diseases, including vasculitis.

8. A Study to Evaluate Proximal Aortic Seal Zone Stress and Strain Following Endovascular Aortic Repair

   Jacksonville, Fla.

   The purpose of this study is to obtain baseline stress and strain of abdominal aortic artery prior to endovascular repair, and to compare the variation in stress and strain of Ovation vs. Cook stent grafts immediately post-operativelythen after 1 month, 3 months, 6 months, and 12 months following endovascular repair.

9. Assessment of the GORE® EXCLUDER® Conformable AAA Endoprosthesis in the Treatment of Abdominal Aortic Aneurysms

   Rochester, Minn.

   The purpose of the study is to assess the safety and effectiveness of the GORE® EXCLUDER® Conformable AAA Endoprosthesis to repair an  aneurysm located in the abdominal aorta. Performance of the GORE® EXCLUDER® Conformable AAA Endoprosthesis will be judged by separate performance goals.

10. A Study to Assess Long-term Symptom Improvement and Recurrence after Operative Management of Popliteal Artery Entrapment Syndrome (PAES)

    Rochester, Minn.

    The purpose of this study is to evaluate long-term symptom resolution and quality of life improvements after operative management of popliyteal artery entrapment syndrome (PAES).

بالأسفل التجارب السريرية الحالية.

غربل قائمة الدراسات هذه بالموقع والحالة وغيرها.

1. A Study to Evaluate Advanced Ultrasound Techniques for Diagnosis of Giant Cell Arteritis

   Rochester, Minn.

   The purpose of this study is to find out if advanced ultrasound studies can be used to make a diagnosis of giant cell arteritis. Ultimately, we hope to be able to offer non-invasive diagnostic options as an alternative to biopsy to future patients who are being evaluated for giant cell arteritis.

    

2. A Study of Atrial Cardiopathy and Antithrombotic Drugs In Prevention After Cryptogenic Stroke

   Jacksonville, Fla.

   The primary purpose of this study is to test the theory that Eliquis (apixaban) is superior to aspirin for the prevention of recurrent stroke in patients with cryptogenic ischemic stroke and atrial cardiopathy.

3. Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial - Hemodynamics (CREST-H)

   Rochester, Minn., Jacksonville, Fla.

   We aim to determine whether cognitive impairment attributable to cerebral hemodynamic impairment in patients with high-grade asymptomatic carotid artery stenosis is reversible with restoration of flow. To accomplish this aim CREST-H will add on to the NINDS-sponsored CREST-2 trial (parallel, outcome-blinded Phase 3 clinical trials for patients with asymptomatic high-grade carotid artery stenosis which will compare carotid endarterectomy plus intensive medical management (IMM) versus IMM alone (n=1,240), and carotid artery stenting plus IMM versus IMM alone (n=1,240) to prevent stroke and death). CREST-H addresses the intriguing question of whether cognitive impairment can be reversed when it arises from abnormal cerebral hemodynamic perfusion in a hemodynamically impaired subset of the CREST-2 -randomized patients. We will enroll 500 patients from CREST-2, all of whom receive cognitive assessments at baseline and yearly thereafter. We anticipate identifying 100 patients with hemodynamic impairment as measured by an inter-hemispheral MRI perfusion "time to peak" (TTP) delay on the side of stenosis. Among those who are found to be hemodynamically impaired and have baseline cognitive impairment, the cognitive batteries at baseline and at 1 year will determine if those with flow failure who are randomized to a revascularization arm in CREST-2 will have better cognitive outcomes than those in the medical-only arm compared with this treatment difference for those who have no flow failure. We hypothesize that hemodynamically significant "asymptomatic" carotid disease may represent one of the few examples of treatable causes of cognitive impairment. If cognitive decline can be reversed in these patients, then we will have established a new indication for carotid revascularization independent of the risk of recurrent stroke.

4. International Bicuspid Aortic Valve Consortium (BAVCon)

   Rochester, Minn.

   Bicuspid aortic valve (BAV) disease is the most frequent congenital cardiac malformation, occurring in 0.5-1.2% of the US population. In young adults, it is generally a benign abnormality; but in older adults it is associated with thoracic aortic aneurysm or dissection in 20-30% of those with BAV. BAV is strongly associated with early development of aortic valve calcification or incompetence in >50% of BAV patients, and accounts for ~40% of the >30,000 aortic valve replacements (AVR) performed in the US each year. Yet, we know little of the etiology, cellular events and modifiers of progression of BAV to calcific aortic valve disease and we still do not understand the genetic cause(s) of BAV despite evidence for its high heritability.

   The Specific Aims of this study are:

   1. To identify the genetic causes of bicuspid aortic valve disease and its associated thoracic aortic disease.

   2. To identify potential pathways to predict the clinical course of BAV disease and for treating human BAV disease.

   To achieve these aims, we have created the International Bicuspid Aortic Valve Consortium (BAVCon), a consortium of institutions with cohorts of BAV patients and the expertise to fulfill the performance of these aims.

5. Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial

   Rochester, Minn., Jacksonville, Fla.

   Carotid revascularization for primary prevention of stroke (CREST-2) is two independent multicenter, randomized controlled trials of carotid revascularization and intensive medical management versus medical management alone in patients with asymptomatic high-grade carotid stenosis. One trial will randomize patients in a 1:1 ratio to endarterectomy versus no endarterectomy and another will randomize patients in a 1:1 ratio to carotid stenting with embolic protection versus no stenting. Medical management will be uniform for all randomized treatment groups and will be centrally directed.

6. The Assessment of Prednisone In Remission Trial - Centers of Excellence Approach

   Rochester, Minn.

   This study is a multi-center randomized controlled trial to evaluate the effects of using low-dose prednisone as compared to stopping prednisone treatment entirely. Participants will be randomized 1:1 to taper their prednisone dose down to 5 mg/day or to 0 mg/day for the duration of the study (approximately six months) or until a study endpoint.

7. Low Dose Naltrexone to Improve Physical Health in Patients With Vasculitis

   Rochester, Minn.

   The purpose of this clinical trial is to determine if low dose naltrexone is effective in improving health-related quality of life (HRQoL) among patients with vasculitis. Although it is a pilot study, a placebo-controlled component is used because of the prominent placebo group effect seen in studies with self-reported subjective outcomes.

   Naltrexone is an FDA approved drug (for alcoholism) that has found widespread use "off-label" to treat pain and improve quality of life at much lower doses than are used for the approved indication. There are a few scientific studies in three conditions (fibromyalgia, Crohn's disease, and multiple sclerosis) that suggest that this drug has benefit and is safe. However, considering the extent of use in other conditions, and uncertainty about the mechanism of action study is needed in a diverse set of diseases, including vasculitis.

8. A Study to Evaluate Proximal Aortic Seal Zone Stress and Strain Following Endovascular Aortic Repair

   Jacksonville, Fla.

   The purpose of this study is to obtain baseline stress and strain of abdominal aortic artery prior to endovascular repair, and to compare the variation in stress and strain of Ovation vs. Cook stent grafts immediately post-operativelythen after 1 month, 3 months, 6 months, and 12 months following endovascular repair.

9. Assessment of the GORE® EXCLUDER® Conformable AAA Endoprosthesis in the Treatment of Abdominal Aortic Aneurysms

   Rochester, Minn.

   The purpose of the study is to assess the safety and effectiveness of the GORE® EXCLUDER® Conformable AAA Endoprosthesis to repair an  aneurysm located in the abdominal aorta. Performance of the GORE® EXCLUDER® Conformable AAA Endoprosthesis will be judged by separate performance goals.

10. A Study to Assess Long-term Symptom Improvement and Recurrence after Operative Management of Popliteal Artery Entrapment Syndrome (PAES)

    Rochester, Minn.

    The purpose of this study is to evaluate long-term symptom resolution and quality of life improvements after operative management of popliyteal artery entrapment syndrome (PAES).