Glossary of CVD Clinical Trial Terms
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.< /p>
Phase I trials — An experimental drug or treatment in a small group of people (20–80) for the first time. The purpose is to evaluate its safety and identify side effects.
Phase II trials — The experimental drug or treatment is administered to a larger group of people (100–300) to determine its effectiveness and to further evaluate its safety.
Phase III trials — The experimental drug or treatment is administered to large groups of people (1,000–3,000) to confirm its effectiveness, monitor side effects, and compare it with standard or equivalent treatments.
Phase IV trials — After a drug is licensed and approved by the FDA, researchers track its safety and seek to understand more about the risks, benefits and optimal long-term use.
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.