The cardiovascular (CV) clinical trials coordinated by St. Vincent Cardiovascular Research Institute in Indianapolis provide an opportunity for men and women with heart and vascular diseases to have access to cutting-edge therapies.
A clinical trial candidate or subject is typically a St. Vincent heart or vascular patient with a specific cardiovascular medical diagnosis. Every clinical trial has a very specific purpose and participant eligibility criteria. Your St. Vincent cardiologist or vascular specialist, along with the CVD Research Team at St. Vincent, will evaluate the criteria to determine if you are a candidate for an appropriate research study. By participating in a study, you agree through the informed consent process to have information collected about your specific cardiovascular condition. The medical data help the physician-researchers and clinicians understand more about specific diseases and how to best treat them. A principal investigator is the medical provider who is in charge of a study. The other physicians from.
St. Vincent who are involved in the study are called sub-investigators. The cardiovascular researchers work closely with the clinical research coordinators (CRC) at the St. Vincent Cardiovascular Research Institute to ensure the protocol is followed and that federal guidelines and Good Clinical Practice (GCP) standards are adhered to.
Before a study can be offered to subjects at St. Vincent, it must be reviewed and approved by an Institutional Review Board (IRB), an ethical committee that formally approves, monitors and reviews any biomedical and behavioral research involving human participants. The purpose of the IRB is to assure that appropriate steps are taken to protect the rights and welfare of all participants in the research study.
Once you are a confirmed participant in a clinical trial, a specific clinical research coordinator (CRC) will help you navigate the experience and is available to get answers to all of your questions at any point in the process.
There are local (institution-specific) research studies and multicenter clinical trials where the same clinical trial is being conducted at more than one medical center or clinic in the U.S. or globally. St. Vincent is often recruited as a multicenter trial site because of our high level of heart care and for the highly regarded expertise of our cardiovascular physicians.
A clinical trial typically falls into one of two categories:
Observational Studies: The purpose of an observational study is to collect patient-specific information (such as gender, race, height, weight and routine blood test results) during a period of time to see how these variables affect a disease.
For example, researchers have learned from several heart failure registries that patients with kidney disease are at higher risk for readmission to the hospital after an initial hospitalization for heart failure. Many of these heart failure observational studies report that the incidence of heart failure in the United States and around the world increases sharply with age, and that hypertension is an important risk factor for the development of heart failure later in life.
Therapeutic Trials: Non-medical, medication or surgical device interventions are studied in a therapeutic trial to see the effect of an intervention on a specific medical condition. Non-medical interventions refer to dietary changes (such as a low vs. high salt diet) or exercise. Therapeutic trials often include patient education sessions to help these individuals better understand their medical condition.
This type of clinical trial is organized with a control group (a group that receives standard therapy but not the new treatment being tested) and a treatment group (the group receiving the new treatment, either in addition to standard therapy or compared directly to standard treatment).
Within a therapeutic trial there are randomized trials and open label trials.
Participating in a randomized trial means the participant is randomly placed in either the control group or the treatment group to ensure a fair comparison. The control group is an important part of the trial.
For example, in a medication therapy trial, the control participants receive the standard treatment and a (sugar) pill (a placebo) with inactive ingredients that look similar to the new medication therapy being tested. Most randomized trials are double-blind, which means the physician-investigator does not know if the patient is in the control or treatment group. A study that is randomized and double-blind removes possible bias on the part of the physician because all patients get the same clinical experience.
The Food and Drug Administration (FDA) usually requires a randomized and double-blind trial with vigorous testing before a new drug or medical device can be approved and used.
In an open label trial the subjects all receive a specific therapy that is being studied. The purpose of an open label trial is to study the safety of a given treatment or intervention. The results from open label participants are compared to historical controls available from other trials or observational studies. Open label trials have limitations, and for this reason St. Vincent cardiovascular researchers and coordinators work very hard to match appropriate patients to these trials for the benefit of enhanced patient safety and outcomes.
A diagnostic trial refers to a study that is evaluating better tests or procedures for diagnosing a particular disease or condition. In these studies, often a radiologist, interventional cardiologist, geneticist and/or pathologist is involved in the study protocol.
A screening trial refers to a study that evaluates the best way to increase early detection of cardiovascular diseases or health conditions with screening tests.
There are many advantages to participating in a research trial.
There are always potential risks for participants in a clinical trial. Patient safety is the primary focus of any study. The physician-researchers must follow ethical principles or rules. Each investigator who conducts a trial has passed coursework in research ethics and patient safety protocols.
In some clinical trials, no demonstrable benefit is discovered by the new treatment. It is possible that instead of the condition getting better, it gets worse. If the investigated drug does not positively affect overall survival but proves to be safe and helps some patients feel better, it may ultimately be approved for compassionate use.
St. Vincent Cardiovascular Research Institute oversees many different types of CVD research studies. Our first priority is the safety and well-being of every participant. Every clinical trial has a protocol to determine how a study is conducted, what type of patients are enrolled, and how to keep the study and its participants safe. The sponsor of the study (the pharmaceutical or device company) creates an independent, external committee to monitor safety known as the data safety monitoring board (DSMB). They meet on a routine basis to review all of the study information and to evaluate adverse results. The DSMB sees information that the site investigators are not allowed to see and with this exclusive perspective can help make the study safer. For example, if the DSMB feels the new treatment or therapy offers overwhelming benefit, they may stop the trial earlier than planned to report the results and to encourage faster acceptance or approval of that new therapy. Likewise, if the DSMB perceives a negative impact from the investigated treatment (more harm than good), the DSMB can stop the trial.
St. Vincent Cardiovascular Research Institute team members follow principles of good clinical practice:
We encourage our clinical trial participants to ask lots of questions of the principal investigator and the St.Vincent clinical research coordinators.
Only you can decide if participating in clinical trials is right for you. Please read the informed consent document carefully before deciding whether you wish to participate. Every consent form is personalized for a specific clinical trial. For example, if you have been enrolled in a previous research study and are now eligible to participate in the next phase of that trial or a different research study, the informed consent will be different for each trial.
Informed consent is a process used by researchers to provide potential risks and benefits and enrolled participants with information about a clinical study. This information helps people decide whether they want to enroll or continue to participate in the study.
Get all of your questions answered up front
The informed consent process is intended to protect participants and should provide enough information for a person to understand the risks of, potential benefits of, and alternatives to the study. If you have any questions, talk with the St. Vincent cardiovascular physician identified as the principal investigator and/or call the clinical research coordinator at the St. Vincent Cardiovascular Research Institute, 317-338-9337.
The informed consent document - A person must sign an informed consent document before joining a study to show that he or she was given information on the risks, potential benefits, and alternatives, and that he or she understands them. Signing the document and providing consent is not a contract. Participants may withdraw from a study at any time, even if the study is not over.
The informed consent document explains:
Additional Informed Consent Guidelines
Digital content and communication and/or printed material are shared to increase awareness about a research study and the open enrollment opportunities available to adult men and women.
Interested participants will have one-on-one conversations with the cardiologists or the vascular specialist leading the research study and the clinical research coordinator at the Institute.
Depending on the type of trial, the clinical research coordinator may use survey tools to measure a participant’s understanding of the informed consent.
Many of these questions will be answered in the informed consent document associated with a specific clinical trial. This list of commonly asked questions is offered as a starting point for your discussions with our research team.
Cardiac Catheterization (Cardiac Cath or Heart Cath) – This minimally invasive test is done by an interventional cardiologist to check your heart function and to detect possible defects or abnormalities. Through a small incision, a thin, flexible tube called a catheter is inserted into the heart through blood vessels.
Clinical Research – Medical research that involves people to test new treatments and therapies.
Clinical Trial – A medical research study in which one or more human subjects are assigned to the control group or treatment group to evaluate the effects of an investigated treatment (non-medical treatment, medication therapy, or surgical intervention). For more information see http://www.clinicaltrials.gov. Each study record includes a summary of the study protocol, including the purpose, recruitment status, and eligibility criteria.
Clinical Trial Participant or Candidate – A person selected based on medical history who participates in clinical research to test a new drug, device or intervention.
Clinical Research Coordinator (CRC) – The person responsible for conducting the clinical trial using good clinical practices at a specific site under the supervision of the principal investigator (PI).
Cohort Study – A type of observational medical study (also called a panel study) used over a period of time.
Comorbidity – The presence of two or more diseases in one individual.
Case Report Form (CRF) – The document the Research Coordinator enters data that is collected throughout the trial. This may be an electronic, web-based site or a paper binder. A research subject is assigned a subject number and that number is used to identify the subject throughout the life of the trial.
CVD – Cardiovascular disease, the focus of all of the heart and vascular disease research efforts at St. Vincent Cardiovascular Research Institute (CVRI).
Data Safety Monitoring Board (DSMB) – This group of scientific research professionals is established by the sponsors of clinical trials as an independent, non-partial review of all of the study information. The DSMB also evaluates adverse results.
Diagnostic Trials – Physician-researchers are studying better tests or procedures for diagnosing a particular disease or condition. In these studies, often a radiologist, interventional cardiologist, geneticist, and/or pathologist is involved in the study protocol.
Double-Blind Studies (Also Called Double-Masked Studies) – Studies in which the participants do not know which treatment is being used. The data safety monitoring board knows, but the physician-researcher on site does not know if the patient is getting the treatment drug or a placebo. Having a randomized – double-blinded study provides unbiased information by those directly involved.
Eligibility Criteria – The key standards and characteristics an individual must have to be considered as a clinical trial participant. Eligibility Criteria will include both inclusion criteria and exclusion criteria. For example, a research study might only be accepting participants who are above or below a certain age.
Informed Consent Form (ICF) – This form summarizes how the clinical trial will be done and explains the risks and potential benefits of the clinical trial before someone decides whether to participate.
Institutional Review Board (IRB) — An independent ethics committee that formally approves, monitors and reviews any biomedical and behavioral research involving humans.
Left Ventricular Assist Device (LVAD) – A device that is surgically implanted in the chest to help pump blood from the left ventricle of your heart and on to the rest of your body.
Multicenter Clinical Trial – A multicenter research trial is a clinical trial conducted at more than one medical center or clinic in the U.S. or globally. Most large clinical trials, particularly Phase III trials, are conducted at several clinical research centers. St. Vincent Heart Center is often recruited as a multicenter trial site because of its high level of heart care and the highly regarded expertise of these cardiovascular physicians.
NLM's MedlinePlus® Website – MedlinePlus has information about diseases, conditions and wellness issues for patients and their families. Each of the health topics on MedlinePlus provides information from NIH and other trusted sources. Helpful resources include: MedlinePlus: Clinical Trials Health Topic; and MedlinePlus: Understanding Medical Research
Observational Studies – The purpose of an observational study is to collect patient-specific information (such as gender, race, height, weight and routine blood test results) during a period of time to see how these variables affect a disease.
Non-medical Interventions – Cardiovascular treatments that utilize dietary, exercise and lifestyle changes.
Phases of Clinical Trials – Clinical trials are conducted in “phases.” The trials at each phase have a different purpose and help researchers answer different questions.
Placebo – A placebo pill or liquid looks like the new treatment but does not have any treatment value from its active ingredients.
Principal Investigator (PI) – The physician-researcher who leads the clinical research team and, along with the other members of the research team, regularly monitors study participants’ health to determine the study’s safety and effectiveness.
Quality of Life (QoL) – The measure of the general well-being of an individual. QoL is often a parameter of clinical trials and participants will be asked to evaluate their QoL at different points in the trial. A trial that assesses QoL may also refer to supportive care and explore ways to improve the comfort and quality of life of people with a chronic illness.
Randomized Study – The process by which two or more alternative treatments are assigned to different study participants by chance rather than by choice.
Screening Trials – A study may evaluate the best way to detect certain diseases or health conditions with screening tests.
Stent – A tube-like device that is inserted to open a blocked artery. A stent can be inserted into an artery supplying blood to the heart (coronary artery) or a blocked artery in a leg.
Study Protocol – A written description of a clinical study. It includes the study's objectives, design and methods. It may also include relevant scientific background and statistical information.
Therapeutic Trials – These treatment trials test new interventions which can include non-medical, medication or surgical device interventions. In a therapeutic trial the physician-researchers are evaluating the effect of an intervention on a specific medical condition.
Family support is a very important part of any patient’s journey and loved ones are encouraged to be involved during participation in a clinical trial. As caregivers, family members and friends provide unconditional emotional and physical support. Participants in clinical trials will have regular follow-up appointments at St. Vincent. Please communicate with your clinical research coordinator (CRC) if any problem arises while participating in the clinical trial, including problems arranging transportation to and from the visit.
Helpful tip: Encourage the participant to keep a journal for questions, to record symptoms and reflections on one’s quality of life throughout the clinical trial experience. Periodic patient surveys are done as part of some of the clinical trials. A journal is a helpful tool to recall specific experiences, lifestyle changes, stressors, sleep habits, dietary and exercise, and other factors that affect our daily lives and total heart health.
At St. Vincent we provide a holistic approach to care, which means we care for the body, mind and spirit. If at any point in your caregiving you need to talk to someone about home care, pastoral care, or other forms of supportive care, talk to your CRC about the resources available to you and your loved ones through St. Vincent.
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