Cardiovascular

Official Title IMPROVE-AD Trial: IMPRoving Outcomes in Vascular DisEase – Aortic Dissection

Purpose

The goal of this study is to figure out the best way to treat type aortic dissection. An aortic dissection is a tear in the wall of the aorta. The aorta is a big blood vessel that carries blood from your heart to the rest of your body. Individuals with this problem usually get medicine or a special repair procedure. This procedure is called thoracic endovascular aortic repair (TEVAR). TEVAR is a procedure where a metal tube (called a stent), is inserted in the damaged part of the aorta. The study is being done to figure out which treatment works better. The results of the study may help to prevent future problems with the aorta or other health issues. 

 

Could this study be right for you?

Inclusion:

• Age > 21 years
• Stanford type B aortic dissection not involving the aorta at or proximal to the innominate artery, without rupture and/or malperfusion (renal, mesenteric, or extremity)
• Acuity: within 48 hours – 6 weeks of index admission

Exclusion criteria:

• Ongoing systemic infection
• Pregnant or planning to become pregnant in the next 3 months
• Life expectancy related to non-aortic conditions < 2 years
• Prior surgery for aortic dissection

Age Range

21 years and up

Official Title AAA-SHAPE Pivotal Trial: Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion

Purpose

The purpose of this research is to determine if the IMPEDE-FX RapidFill System is safe and helps to shrink abdominal aortic aneurysm (AAA - a bulge or swelling due to weakening of the walls of the aorta, which is the main blood vessel that carries blood from your heart to other parts of your body) sacs after an endovascular stent graft (a fabric tube supported by metal wire stents that reinforces a weakened aorta) has been placed. The IMPEDE-FX RapidFill System used in this study is classified as investigational, which means it has not been approved by the Food and Drug Administration (FDA).

Could this study be right for you?

Inclusion:

• A candidate for elective EVAR of an infrarenal fusiform aortic aneurysm ≥5.5 cm in diameter in men and ≥ 5.0 cm in women 
• Thrombus burden (percentage of the AAA sac occupied by thrombus) <50%, based on pre-procedure CTA
• Maximum Lumen diameter within the AAA sac of ≥40mm
• The predicted minimum number of IMPEDE-FX RapidFill Implants for the subject is ≤200

Exclusion:

• An inability to provide informed consent
• Enrolled in another clinical study that could interfere with the outcomes being studied in this trial
• Unable or unwilling to comply with study follow-up requirements

Inclusion and Exclusion Criteria varies, please contact Study Coordinator for more information. 

Age Range

18 years and up

Official Title The mom and infant outcomes (MOMI) study: A trial of perinatal outpatient delivery systems

Purpose

​To improve our ability to provide the best possible care to every mom and infant, we are testing two different models of primary care during the first year after childbirth.

Could this study be right for you?

- You may qualify if you’re currently pregnant – AND – you’ve ever had high blood pressure, diabetes, depression, or anxiety, including during pregnancy.

- If you participate, you’ll be randomly assigned to an Ohio State location that delivers one of two models of care. Providers at all locations can help you manage your health, but the models differ in several ways.

- You’ll complete three study visits with surveys, several measurements, and blood and hair sampling. We’ll collect cord blood and review medical records. 

Official Title Patterns Of Survivors’ Recovery Trajectories in the ICECAP trial 􀂥POST-ICECAP􀂦

Purpose

The purpose of this study is to describe the physical, neuropsychological outcomes of adults who have experienced an outside of hospital cardiac arrest; and examine any associations between those outcomes and any clinical and/or rehabilitative interventions and/or social determinants of health.

Could this study be right for you?

• Experienced a coma after resuscitation from a cardiac arrest
• Received targeted/controlled body temperature management
• Survived to at least 1 month after experiencing a outside of hospital cardiac arrest

Age Range

18 years and up

Official Title A prospective randomized unblinded study of ketogenetic versus mixed diet on exercise tolerance in subjects with the metabolic phenotype of heart failure with preserved ejection fraction

Purpose

The purpose of this study is to compare the effects of a well-formulated ketogenic diet with a low-fat diet on exercise tolerance in patients with heart failure and diabetes or pre-diabetes or metabolic syndrome.

 

Could this study be right for you?

• Age ≥ 18 years old and ≤ 80 years old & willingness to be randomized to either diet.
• NYHA class I – III for at least 3 months.
• Ejection fraction ≥50% by biplane 2D, or 3D echo, or CMR
• Echo findings of abnormal or indeterminant diastolic function or RHC data:  At rest: mean pulmonary capillary wedge pressure (PCWP) > 15 mmHg.  pulmonary vascular resistance (PVR) < 3 Wood Units.
• Stable medical therapy for at least 3 months as determined by the treating physician (no new cardiac or diabetic medications within 3 months of enrollment or during enrollment and dosage should be stable for 1 month prior to enrollment).
• Dose of oral diuretics changes allowed but must be stable for 1 week prior to randomization.
• Body Mass Index (BMI) ≥ 25 and ≤ 50 or Type 2 Diabetes Mellitus or prediabetes (fasting glucose of 100 - 125 mg/dL or hemoglobin A1C 5.7-6.4%) or metabolic syndrome.
• Ability to participate in exercise treadmill testing.
• Ability to sign written consent.

Exclusions:

•  Women who are pregnant, current breast-feeding, or have intention to become pregnant while in the study.
•  Known allergy or sensitivity to gadolinium-based contrast agents.           
• Implanted pacemaker, cardioverter defibrillator, Cardiac resynchronization therapy, left ventricular assist devices.
• Other metallic implants/aneurysm clips that are contraindicated in MRI.           
• Claustrophobia
• History of severe kidney disease of eGFR<30 ml/kg/1.73m2.

 

Exclusion Criteria varies, please contact Study Coordinator. 

Age Range

18 - 80 years

Official Title PRagmatic EValuation of evENTs And Benefits of Lipid-lowering in oldEr adults

Purpose

The purpose of PREVENTABLE is to learn if taking a statin could help older adults live well for longer by preventing dementia, disability, or heart disease. The duration of the study will last 5 years. 

Could this study be right for you?

Inclusion Criteria:

• Community-dwelling adults
• Age ≥75 years
• English or Spanish as primary language

 

Exclusion Criteria:

• Clinically evident cardiovascular disease defined as prior myocardial Infarction (MI), prior stroke, prior revascularization procedure, or a secondary prevention indication for a statin (clinician determined)
• Hospitalization for a primary diagnosis of heart failure in the prior 12 months (Note: History of heart failure in the absence of recent hospitalization or clinically evident cardiovascular disease is not an exclusion)
• Dementia (clinically evident or previously diagnosed)
• Dependence in any Katz Basic Activities of Daily Living [ADL] (with the exception of urinary or bowel continence)
• Severe hearing impairment (preventing phone follow up)
• Unable to talk (preventing phone follow up)

Exclusion Criteria varies, please contact Study Coordinator for more information. 

Age Range

75 years and up

Official Title A Multicentre, Randomised, Double-blind, Parallel-group, Placebo-controlled, 24-week Phase 3 Study with an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab in Patients with Hypereosinophilic Syndrome (HES)

Purpose

The purpose of this study is to see if benralizumab (biologic drug), given as injections under the skin, can help control your Hypereosinophilic Syndrome (HES) better if it is added to available standard of care HES medications which you may be currently taking. 

HES (Hypereosinophilic Syndrome) is a disease characterized by high levels of eosinophils (a particular type of white blood cell) in your blood and a build-up of eosinophils in some organs and tissues (like skin, heart, lungs, intestines or others) causing their dysfunction.

The duration of the study will last 18 months.

Could this study be right for you?

 

• Eosinophil (a type of white blood cells) count ≥ 1000 cells/μL at screening
• Documented diagnosis of Hypereosinophilic Syndrome (HES)
• History of persistent eosinophilia >1500 cells/μL (at least 2 examinations, interval ≥1 month)
• End organ manifestations attributable to the eosinophilia

Inclusion and Exclusion Criteria varies, please contact Study Coordinator for more information.

Age Range

18 years and up

Official Title BUckeye Concussion Knowledge Survey (BUCKS)

Purpose

The purpose of this study is to examine health outcomes in former Ohio State University athletes who played a varsity sport during their time at OSU. The objective is to determine whether athletes who sustained a concussion have different health outcomes than those who did not sustain a concussion. Any former OSU varsity athlete can participate in a 20-minute online survey.

Could this study be right for you?

• Anyone who has played a varsity sport as an undergraduate student at OSU, and they have now graduated (i.e., OSU athlete alumni). There are no other restrictions in terms of age, sex/gender, type of sport, etc.

Age Range

18 years and up

Official Title Mobile Health App as a Cardiotoxicity Symptom Logging Tool: Feasibility Pilot Study

Purpose

To evaluate the cardio-oncology patient population’s experience with using smart-phone technology as a part of self-management with their care through features such as symptom logging and education. Eligible patients will be asked to participate in a 30-minute virtual interview and/or a 60-minute virtual design or usability session to discuss their thoughts on a mobile app for cardio-oncology patients.

Could this study be right for you?

- English-speaking - Prior cancer diagnosis - Currently undergoing a cancer regimen that includes a targeted, biologic, radiation, and/or immune-based therapy (ex. TKIs and/or ICIs). - No pregnant females - No prisoners

Age Range

18 and up

Official Title Measurement of Mitochondrial Dysfunction Using Phosphorus Magnetic Resonance Spectroscopy in Diabetic Patients Undergoing an Exercise Regimen

Purpose

We are looking at parts of the cells in our bodies (called mitochondria). Mitochondria give our cells energy and help them stay healthy. People with diabetes have mitochondria which do not work as well as the mitochondria in people without diabetes.

In this study, we want to see if exercise (cardiac rehabilitation) will cause your mitochondria to work better. Using a magnetic resonance imaging (MRI) machine, we can measure how much your cardiac rehabilitation has helped your mitochondria. We will be looking at your leg muscle and the mitochondria in those cells.

In this study, we hope to show that we can help those with diabetes by making their mitochondria work better using things like exercise. We will be looking for people who are beginning cardiac rehabilitation, some with and some without diabetes.

Could this study be right for you?

- 18 yrs and older
- Have been referred for cardiac rehabilitation
- Are able to have an MRI (study coordinator can screen you for this)

Age Range

18 and up