The Sydell and Arnold Miller Family Heart & Vascular Institute at Cleveland Clinic participates in a wide range of research studies and large randomized controlled trials, which help guide evidence-based patient care and national practice standards.
We are currently enrolling cardiovascular medicine and surgery patients for clinical trials that look at ways to improve the care of patients. You may qualify to take part in a trial that tests different methods of treatment, such as surgical procedures, devices or new medicines.
"Clinical trial" is the scientific term for a test or study that evaluates new surgical procedures, devices or medicines. Clinical trials are done to see if these procedures can safely and effectively treat or cure disease. Doctors and other health professionals conduct clinical trials according to strict rules set by the Food and Drug Administration (FDA).
To help you decide if you want to participate in a clinical trial, you will be given complete information about the study before you agree to take part. This is known as informed consent. Participation in a trial is completely voluntary. If you do not wish to participate, your decision will not affect your care or treatment at Cleveland Clinic.
In this section, you will learn about Clinical Trials, C5Research, the Vascular Surgery Academic Research Organization and Core Labs at the Miller Family Heart & Vascular Institute.
The Miller Family Heart & Vascular Institute serves as a clinical research resource for patients, researchers, and healthcare professionals around the globe.
Clinical Trials: What You Need to Know
What is a clinical research trial?»
A clinical trial is a research program conducted with participants to evaluate a new medical treatment, drug or device. The purpose of clinical trials is to find new and improved methods of treating different diseases and special conditions.
There are four phases of a clinical trial:
- Phase I: usually the first time a new treatment, drug or device is used in humans. In this case, the treatment is given to a small number of participants at a very low dose or setting, and increased over time according to the response. The purpose is to determine the best way to give the new treatment and how much of it can be given safely.
- Phase II: determine the effect of a research treatment on a particular disease or condition. Phase II trials involve the development of a protocol, or plan about how the trial will be conducted and how the data will be analyzed. These plans are submitted to a an Institutional Review Board (IRB), who must approve the protocol before the clinical trial begins. The IRB is a group of health professionals and non-medical persons whose job it is to review and monitor clinical research to protect the safety and rights of participants. Some research is also reviewed and monitored by federal agencies (such as the National Institute of Health - NIH, or U.S. Food and Drug Administration - FDA). There may or may not be a control group in a Phase II clinical trial. Control groups receive standard, current care. Treatment groups receive the experimental therapy.
- Phase III: compare the new treatment with the standard treatment on a larger group of participants to determine effectiveness, dosing, and optimal characteristics of a treatment, device or drug. The same review and approval process takes place in a Phase II clinical trial. There is usually a control group and a treatment group. The participant group is chosen based on randomization, or assigning a participant into a group based on chance.
- Phase IV: This phase of research is conducted after approval has been given by the FDA. The purpose of Phase IV research is to learn more about how the treatment, drug or device works in a larger population of participants or to determine clinical advantages of a specific treatment.
What does it mean to participate in clinical research?»
Who can participate?
Every clinical trial is designed to look at a specific set of participants. Each study enrolls participants with certain conditions and symptoms. If you fit the guidelines, you may be able to participate. In some instances, you may be asked to undergo certain tests to make sure you are appropriate for the study.
What are the advantages?
During a clinical trial, Investigators use the best treatment available as a standard to evaluate new treatments. The new treatments are at least as effective or possibly more effective than standard. If you participate:
- You may receive a new treatment before it is widely available to the public
- You can provide researchers with the information they need to continue developing new procedures and treatment methods
- Your treatment costs may be decreased (many of the tests and Investigator visits that are directly related to the study are paid for the company or agency conducting the clinical trial).
Could there be side effects?
Yes. Side effects will depend on the type of treatment and the participant's condition. All of the risks and side effects of the treatment being researched are not known at the beginning of the clinical trial. Since this is the case, there may be unknown side effects, as well as hoped for benefits.
It is important to note that most treatments, as well as the condition itself, have potential side effects. In clinical trials, most side effects from the treatment are temporary and go away once the treatment is stopped. participants will be informed of any known possible side effects that occur while they are participating in a trial.
What is informed consent?
- Informed consent means that as a participant, you are given all the available information so that you understand what is involved in a specific clinical trial. Your doctor or nurse should explain the treatment to you, including benefits and risks.
- You will be given an informed consent form. Read it and consider it carefully. Ask the Investigator or nurse to explain any parts of the form that are not clear.
- You are free to decide whether or not to take part in the trial. If you decide to take part in the study, you will sign the consent form. If you do not want to participate in the trial, you can say "No." If you choose not to participate in the trial, your care will not be affected in any way.
- After you sign the form, you will receive a copy. It contains important information that you may refer to during the trial.
Questions to ask your doctor»
If you are thinking about taking part in a clinical trial, find out as much as possible about the study before you decide to participate. Here are some questions you may want to ask your doctor or nurse?
- What is the purpose of the study?
- What have previous research of this drug or treatment shown?
- What kinds of tests and treatments does the trial involve? How are these tests given?
- What is likely to happen in my case with, or without, this new research treatment? (How does this research study compare with standard treatment options?)
- What phase is this clinical trial?
- How could the clinical trial affect my daily life?
- What side effects can I expect from the clinical trial? (Remember, there can also be side effects from standard treatments and from the disease itself)
- How long will the study last?
- Will the clinical trial require extra time on my part?
- Will my records remain confidential?
- Will the study cost me anything?
- Will I have to be hospitalized? If so, how long and how often?
- If I agree to withdraw from the clinical trial, will my care be affected? Will I need to change doctors?
(Adapted from Clinical Trials: A guide for patients, The Cleveland Clinic Foundation, 1995)
For more information:
Information on this page from, "Should I Enter a Clinical Trial? A Patient Reference Guide for Adults with a Serious or Life-Threatening Illness." Written by ECRI *(formerly the Emergency Care Research Institute) with an educational grant from Pfizer, Inc. to the American Association of Health Plans, 2002.
The Miller Family Heart & Vascular Institute at Cleveland Clinic offers a variety of resources to provide:
- comprehensive coordination and management of clinical trials
- advanced diagnostic technology
- standardized, independent measurements
- increased accuracy and precision, and unbiased interpretation of results
- a world class team of physicians, project managers, biostatisticians and technicians with clinical and research expertise
Core laboratories can enhance the scientific potential of research trials by providing highly specialized data related to the main question posed by the study, and also by allowing to test additional hypotheses formulated during the conduction of the trial or after its termination.
Visit the Core Lab categories listed to the above for more information. Additional Miller Family Heart & Vascular Institute Core Laboratories can be found within the Vascular Surgery Academic Coordinating Center (ACC) Organization.
Find more information about research activities at the Cleveland Clinic from the Lerner Research Institute website
The Center for Cardiovascular Diagnostics and Prevention is a joint effort of Preventive Cardiology, Molecular Biology, and the Cleveland Clinic Cardiovascular Coordinating Center. Our focus is to provide laboratory blood tests for researchers and Clinical Trials. We are also developing new markers of cardiac risk and disease. The testing we provide ranges from the routine (e.g. cholesterol, liver enzymes, high sensitivity CRP) to the esoteric (cytokines such as IL-6, thrombosis related such as PAI-1) to tests available nowhere else (Myeloperoxidase, nitrotyrosine, and arginine metabolites). For studies we provide input on protocols, sample collection, prepare collection kits, arrange logistics, specimen storage, specimen analysis and data management. The Center, with the section of Preventive Cardiology, is also involved in programs to increase wellness.
Prevention Research Laboratory (PRL)»
Director - Frederick van Lente, PhD
Manager - Alan Pratt
Assistant Manager - Sarah Neale
PRL is a clinical reference laboratory in Preventive Cardiology under the direction of Frederick van Lente, Ph.D. that specializes in assays measuring markers of inflammation that are predictive for heart disease.
Molecular Diagnostics Laboratory»
Director: Stanley Hazen, MD, PhD
The Molecular Diagnostic Lab is a research laboratory in the Department of Cell Biology that studies:
- The role of myeloperoxidase in oxidant stress and atherosclerosis
- Eosinophil peroxidase and the origins of tissue injury in asthma
- Pathways mediating oxidative damage in cancer
Under the direction of Stanley Hazen, MD, PhD the Molecular Diagnostic Lab generates independent research and works in partnership with PRL to develop and validate new assays related to atherosclerosis and heart disease.
Mass Spectrometry II Core Laboratory»
Director: Renliang Zhang MD, PhD
The Mass Spectrometry II Core Laboratory is designed to meet the growing needs of investigators for development of analytical methods for identification and quantification of biomarkers in plasma, tissue and other biological materials. The main focus of this core is quantitative analysis of small molecules in complex matrices and structural characterization of small compounds. The core offers the service for the investigators to develop analytical methods for:
- Identification of novel bioactive compounds
- Quantification of biomarkers in biological materials like plasma, urine and tissues
The Mass Spectrometry II Core is equipped with a triple quadrupole mass spectrometer (Micromass Quattro Ultima) and two HPLC systems:
- The mass spectrometer has two ionization sources available: electrospray ionization (ESI) and atmospheric pressure chemical ionization (APCI). The effective mass range is 4180 Da for singly charged species
- Waters model 2690 HPLC equipped with a Waters 996 Photodiode Array Detector and a 5 tray, 24 sample/tray auto-sampler. This instrument is coupled with Quattro Ultima mass spectrometer
- Beckman 126 HPLC equipped with a 96 samples auto-sampler, both a 168 Photodiode Array Detector and a Jasco FP-1520 fluorescence detector.
Why use the Center for Cardiovascular Diagnostics and Prevention?»
The Center has an outstanding level of accuracy and reliability. For example, our lipid assays are standardized with the Center for Disease Control and the Lab is accredited by the College of American Pathologists and C.L.I.A. Analyses for each study are run in ways to reduce variance and close attention is paid to each specimen. Costs are kept to minimum while ensuring the finest quality. Our test menu is constantly increasing, feel free to contact us for details.
In the area of Cardiac Research there is a great deal of interest in inflammation and compounds related to inflammation. Indeed one can argue that almost every disease has an inflammatory component. Many inflammatory related assays are now available for research studies. The best known is High Sensitivity-CRP which has been called “the new Cholesterol”. We are truly excited about Dr Hazen’s new markers of Cardiovascular Disease. The Center has taken that one step further with MPO or Myeloperoxidase which may prove to be the next “new cholesterol”. MPO is active agent in inflammation and tissue damage. The Center also measures oxidatively modified Amino acids which are markers of tissue damage.
Prevention Research Lab
Sarah Neale MS firstname.lastname@example.org
Mike Pepoy BS email@example.com
Alan Pratt BS MT (ASCP) firstname.lastname@example.org
Phone: 216.444.5447 and 216.444.3136
Molecular Diagnostics Lab
Phone: 216.445.1900 (Lab)
Mass Spectrometry II Core Lab
Renliang Zhang MD, PhD Zhangr1@ccf.org