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Cardiac Research

What is Clinical Research?

Clinical Research is the study of the safety and effectiveness of medications, devices, diagnostic products and treatment regimens intended to advance medical knowledge in human participants.

A clinical trial participant may be involved in a study for a medication/drug not yet approved by the FDA, or to further evaluate/compare one already approved.

A study may also find that a drug approved for another indication (use) may work for a disease or use they didn’t study before.

Advancements in medicine are only possible with the participation of volunteers in research. We couldn’t do it without you!

Participation is always voluntary and does not affect the care you receive by your cardiologist.

Clinical Trial Opportunities

Colorado Springs Cardiology is currently enrolling in clinical trials for people with atrial fibrillation, high LDL cholesterol, heart failure, or recent heart attack. You may be compensated for time and travel. We have over 20 years of experience conducting clinical trials so that we may help provide more treatment options to our patients. We are constantly starting new studies in various cardiovascular areas.

These may be devices or drugs already approved by the FDA or being investigated to receive FDA approval. We also participate in registries and studies developed by physicians or mid-levels in our practice. Please ask a research coordinator if you might qualify for one of our research studies.

Colorado Springs Cardiology conducts Phase 2, 3 and 4 studies for devices and medications. Studies in these phases may be randomized, where a computer decides which treatment you receive. They may also be blinded, where you and/or your study team does not know which treatment you are receiving. Many studies are randomized and blinded.

A phase 2 study determines the effectiveness of a drug/device on a particular disease and can help decide how much and how often to take a drug. These studies may only involve 100-300 participants.

A phase 3 study typically involves several hundred to several thousand patients and gathers continued data on drug’s safety and effectiveness. FDA approval may be requested after a phase 3 study is completed.

A phase 4 study is conducted after a drug (or other treatment) has already been approved by the FDA. These studies involve thousands of participants and determine long-term safety and effectiveness. They occur over many years and help to identify adverse effects that were not apparent in previous trials.

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About the Research Center

Clinical research is currently available at Penrose and St. Francis Colorado Springs Cardiology locations. We have many providers in the practice who are involved in research and have more than 20 years of experience as research investigators. We have two Clinical Research Coordinators dedicated to research at Colorado Springs Cardiology. Our research facility works in conjunction with Penrose and St. Francis Hospitals to have access to patient exam rooms, electrocardiograms, echocardiograms, laboratory for specimen collection and processing, -20 to -80 freezers for specimen storage, and other specialized testing or procedures necessary for your study participation and safety.

We have conducted studies with Medtronic, Duke University, Abbott, Boston Scientific, American Heart Association, Bayer, and Novartis.

We look forward to adding more sponsors to our list to bring the most appropriate studies to our patients.

What To Expect If You Qualify For A Research Study

Your care team at Colorado Springs Cardiology and our research coordinators will review your medical records to determine if you may qualify to participate in a research study. If you qualify for further screening a research coordinator will reach out to you to schedule a consent and screening appointment. This will include reviewing the consent with you and allowing you and your family to review the consent and ask appropriate questions. Your visit may also include various tests to determine if you are eligible to join the study (i.e. EKG, imaging, blood tests, and/or physical exams).

If you are eligible to and decide to join the study (you may withdraw from the study at any time), you will be scheduled for follow-ups according to the requirements of the study.

The frequency, how long you are in the study, and what is required of you during the study, will be determined by the study you have consented to.

A prinicipal investigator is the practitioner at our clinic who is responsible for conducting the study at Colorado Springs Cardiology. They may or may not be your assigned cardiologist. You will continue to receive the care you would normally receive at our clinic during your participation in the research study.

We look forward to hearing from you!

Please call the research department at 719-776-5233 if you would like more information on our current research studies.

You may also discuss research opportunities with your clinic staff and they can direct you to a research coordinator.

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Some Research Studies at Colorado Springs Cardiology

You may look up any study at clinicaltrials.gov for an overview of the study.

We have many upcoming studies for 2023 and will update our list as we start the new studies. New studies will include drug studies for atrial fibrillation, Myocardial Infarction (heart attack), and device studies.

Please let our staff know if you find a study on clinicaltrials.gov that you think our site should participate in. We may be starting it soon or haven’t seen it yet!

Victorion Inception

Studying an LDL (cholesterol) lowering drug for patients with a recent heart attack. FDA approved drug Inclisiran. Randomized, you may or may not receive the study drug, but if you do the drug is provided to you during your participation in the study.

FINEARTS

Drug for patients with a recent Heart Failure Hospitalization. Randomized and Blinded. Drug is provided to you, but you do not know what you are taking.

Product Surveillance Registry

Patients who have had a recent Medtronic Device implanted.

AFCOG

Cognitive Study for atrial fibrillation patients. Study to determine if there is a cognitive difference between patients who are in an episode of afib versus when they are not in afib. Testing can be completed on your computer at home or on a tablet in our office.

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Please call the research department at 719-776-5233 if you would like more information on our current research studies.

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