Clinical Research

Clinical research is important because it can show researchers what does and doesn’t work. Some studies are designed for, or include, people who are healthy but want to help find ways to prevent a disease, such as one that may be common in their family. Volunteers who take part in clinical trials make valuable contributions to advancing the understanding of diseases and the discovery of new or improved treatments.

• Qualify – Clinical trial participants must meet certain criteria like age, type of disease, previous treatments, and other medical conditions. Your healthcare professional will help determine if you are a candidate for the trial.
• Consent – Before participating, your health care professional or research study coordinator will share the details about the study. They will explain things like the purpose of the study, potential benefits, side effects, treatment plan and duration. If you agree to participate, you will sign an informed consent document. You should not sign this consent unless all your questions have been answered. A copy of the consent will be provided to you.
• Participate – Once you agree to participate, you may have tests and procedures associated with the clinical trial guidelines. The study coordinator is responsible for ensuring all guidelines are followed and to help keep participants safe. Your participation is voluntary, and you may change your mind at any time during the clinical trial.

Also known as congestive heart failure. Heart failure occurs when the heart doesn't pump blood the way it should. When this happens, blood often backs up and fluid can build up in the lungs, causing shortness of breath.

The most common irregular heart rhythm that starts in the atria of the heart. Normally, a healthy heart contracts and relaxes to a regular beat. In atrial fibrillation, the upper chambers of the heart (the atria) beat irregularly (quiver) instead of beating effectively to move blood into the ventricles.

This disease is caused by the buildup of plaque in the arteries that supply oxygen-rich blood to your heart. Over time, the plaque buildup causes the inside of the arteries to narrow, which decreases the amount of blood flow going through the body. This can create chest pain and shortness of breath, as well as increasing the chances of a heart attack if the artery becomes blocked.

Peripheral vascular disease (PVD) is a blood circulation disorder that causes the blood vessels outside of your heart to narrow, block, or spasm. While the legs and feet are mostly affected, major organs, such as the brain, may also suffer from not getting enough blood flow.

GUIDE-HF

This study will evaluate whether treatment with FDA-approved heart failure monitor improves survival and outcomes for NYHA Class II-IV heart failure patients.

Oasis 9

This is a randomized controlled trial testing two inexpensive generic medications (colchicine and spironolactone) to reduce damage to the heart and prevent future cardiac outcomes after heart attack that requires immediate stent placement.

STEMI-DTU

This randomized controlled trial enrolls patients undergoing treatment for a STEMI heart attack. Half the patients will be randomized to receive delayed reperfusion after 30 minutes of left ventricular unloading with the Impella CP®. The other half will receive immediate reperfusion, the current standard of care. The trial will test the hypothesis that unloading the left ventricle for 30 minutes prior to reperfusion will reduce myocardial damage from a heart attack and lead to reduction in future heart failure-related events.

Promise II

This trial is studying whether an investigational, minimally invasive medical procedure, that avoids major surgery, can prevent foot or lower leg amputation and promote wound healing.

Patient Population (not full list of inclusions)

May or may not have been diagnosed with Chronic Limb-Threatening Ischemia, non-healing foot ulcers, doctor’s recommendation to consider amputation of the foot or leg and not eligible for further conventional endovascular or surgical treatments to resolve artery blockage.

iCLAS

The purpose of this study is to test the safety and effectiveness of the Adagio Medical iCLAS™ System when used in the treatment of persistent atrial fibrillation. The device is an investigational type of ablation technology that uses very low freezing temperatures.

Patient Population (not full list of inclusions)

• Currently scheduled for an ablation of symptomatic PsAF defined as continuous atrial fibrillation that is sustained between 7-days and 12 months.

Real AF Registry

The purpose of this research is to find out more about the outcomes for patients who receive an ablation as treatment for Paroxysmal Atrial Fibrillation (PAF) and Persistent (PsAF) Atrial Fibrillation.

Patient Population (not full list of inclusions)

• Patients 18 years of age or older with symptomatic Paroxysmal (AF episode terminate spontaneously within 7 days) or Persistent (AF sustained beyond 7 days) who, in the opinion of the investigator, are candidates for ablation for atrial fibrillation.

The clinical research trials performed at NMHI are health-related studies involving human subjects and that follow a pre-defined protocol. There are many different types of research protocols; in some studies, patients will receive a drug or device and will be informed about what they are being prescribed while other protocols may have patients “blinded” to what is being assigned.

As a participant in a clinical trial, you will:

• Play an active role in your own health care.
• Possibly gain access to new research treatments before they are widely available.
• Obtain expert medical care at NMHI during the trial.
• Help others by contributing to medical research.

Your participation in a research trial is totally voluntary and you may choose to withdraw from a study at any time.

As a participant in a clinical trial, it is important to understand that risks may be associated with your involvement.

You may experience side effects which are defined as any undesired action or effect of the experimental drug or treatment. The side effects known at the time you enter a trial will be explained to you in detail.

The experimental treatment may not be effective for each participant.

Yes. Most clinical trials provide short-term treatments related to a designated illness or condition, but do not provide extended or complete primary health care. In addition, by having the health care provider work with the research team, you can ensure that other medications or treatments will not conflict with the protocol.

The clinical research team includes doctors, nurses and Clinical Research Coordinators. The team checks the health of each participant prior to entry into the trial, provides specific instructions while participating in the trial and monitors each participant carefully throughout the trial.

All clinical trials have inclusion/exclusion criteria that help to both protect the safety of the patient as well as produce reliable results. The factors that allow someone to participate in a clinical trial are called “inclusion criteria” and those that disallow someone from participating are called “exclusion criteria”. These criteria are based on such factors as age, the type and stage of a disease, medical history and previous treatment, as well as many other medical conditions.