مراكز الأوعية الدموية

بالأسفل التجارب السريرية الحالية.

غربل قائمة الدراسات هذه بالموقع والحالة وغيرها.

1. 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.

2. 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.

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. 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.

5. 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).

6. Treatment of Brain AVMs (TOBAS) Study

   Jacksonville, Fla.

   The purpose of this study is to offer the best management possible for patients with brain arteriovenous malformations (AVMs) (ruptured or unruptured) in terms of long-term outcomes, despite the presence of uncertainty.

7. Angiographic and Psychosocial Evaluation of Peripartum vs. Non Peripartum Spontaneous Coronary Artery Dissection (SCAD

   Rochester, Minn.

   The purpose of this study is to determine differences in clinical and imaging presentation, in-hospital management and prognosis in peri-partum and non-peri-partum SCAD patients.

    

8. Multi-Center Prospective Validation Study of VTE Risk Prediction Tool in Trauma Patients

   Rochester, Minn.

   Almost one-half million people suffer venous thromboembolism annually in the United States, and one-third die from this disease. Massive bleeding from injury accounts for half of early deaths after trauma. This study aims to prevent the deaths and suffering associated with venous thromboembolism and bleeding by identifying the individual person at high risk of these complications in order to take preventive measures.

9. A Study to Analyze Association of Frequent Premature Ventricular Complex with Stroke or Transient Ischemic Attack

   Rochester, Minn.

   The purpose of this study is to verify that high Premature Ventricular Complex (PVC) burden is associated with increased risk of stroke and/or Transient Ischemic Attack (TIA), to examine outcomes such as stroke/TIA, atrial fibrillation/flutter, and all-cause mortality associated with PVCs, and to evaluate whether PVCs are associated with development of appendage dysfunction.

10. A Study to Explore if it is Possible to Successfully Obtain Optical Coherence Tomography (OCT) Imaging and Data While Patients Undergo Brain Surgery

    Jacksonville, Fla.

    The goal of this study is to investigate the feasibility of successfully obtaining intra-operative OCT imaging and data during standard brain surgery.

بالأسفل التجارب السريرية الحالية.

غربل قائمة الدراسات هذه بالموقع والحالة وغيرها.

1. 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.

2. 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.

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. 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.

5. 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).

6. Treatment of Brain AVMs (TOBAS) Study

   Jacksonville, Fla.

   The purpose of this study is to offer the best management possible for patients with brain arteriovenous malformations (AVMs) (ruptured or unruptured) in terms of long-term outcomes, despite the presence of uncertainty.

7. Angiographic and Psychosocial Evaluation of Peripartum vs. Non Peripartum Spontaneous Coronary Artery Dissection (SCAD

   Rochester, Minn.

   The purpose of this study is to determine differences in clinical and imaging presentation, in-hospital management and prognosis in peri-partum and non-peri-partum SCAD patients.

    

8. A Study to Analyze Association of Frequent Premature Ventricular Complex with Stroke or Transient Ischemic Attack

   Rochester, Minn.

   The purpose of this study is to verify that high Premature Ventricular Complex (PVC) burden is associated with increased risk of stroke and/or Transient Ischemic Attack (TIA), to examine outcomes such as stroke/TIA, atrial fibrillation/flutter, and all-cause mortality associated with PVCs, and to evaluate whether PVCs are associated with development of appendage dysfunction.

9. Multi-Center Prospective Validation Study of VTE Risk Prediction Tool in Trauma Patients

   Rochester, Minn.

   Almost one-half million people suffer venous thromboembolism annually in the United States, and one-third die from this disease. Massive bleeding from injury accounts for half of early deaths after trauma. This study aims to prevent the deaths and suffering associated with venous thromboembolism and bleeding by identifying the individual person at high risk of these complications in order to take preventive measures.

10. A Study to Explore if it is Possible to Successfully Obtain Optical Coherence Tomography (OCT) Imaging and Data While Patients Undergo Brain Surgery

    Jacksonville, Fla.

    The goal of this study is to investigate the feasibility of successfully obtaining intra-operative OCT imaging and data during standard brain surgery.