Olive Oil and Cardiovascular Health
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
- Rochester, Minnesota: 13-001080
NCT ID: NCT01983943
Sponsor Protocol Number: 13-001080
About this study
The purpose of this study is to conduct a double-blind, randomized controlled trial (RCT), to determine if six month supplementation of olive oil can improve the health of the blood vessels and improve long term health of the heart and blood vessels, in patients requiring percutaneous coronary intervention (PCI).
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.See eligibility criteria
Patients will be included if they have all of the following
- Age ≥ 18 years old
- Have known diagnosis of coronary artery disease
- Demonstrated endothelial dysfunction (reactive hyperemia - EndoPAT score < 2.0) at time of screening
Patients will be excluded if they have one or more of the following:
- Hypertension (at Screening): any patient with systolic blood pressure (SBP) ≥ 170 mmHg or diastolic blood pressure ≥ 110 mmHg, or hypotension (SBP < 100 mmHg)
- Uncontrolled Diabetes Mellitus
- Experienced an acute coronary syndrome within 3 months
- PCI or revascularization for an acute coronary syndrome within 3 months
- Second (II) or third (III) degree heart block without a pacemaker and/or concurrent potentially life threatening arrhythmia or other uncontrolled arrhythmia
- Congestive heart failure NYHA class III and IV
- Unstable serum creatinine (>2.0)
Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of the olive oil including, but not limited to, any of the following:
- History of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection
- Any history of pancreatic injury, pancreatitis or evidence of impaired pancreatic function/injury as indicated by abnormal lipase or amylase
- Evidence of hepatic disease as determined by a history of hepatic encephalopathy, a history of cirrhosis, esophageal varices, or a history of portocaval shunt
- Any concurrent life threatening condition with a life expectancy less than 2 years
- History or evidence of drug or alcohol abuse within the last 12 months
- History of hypersensitivity to any of the study drugs or to medications belonging to the same therapeutic class as the study drugs as well as known or suspected contraindications to the study drugs
- History of noncompliance to medical regimens or unwillingness to comply with the study protocol
- History of malignancy other than basal cell skin cancer within the past five years
- Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study
- Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer
- Any condition that in the opinion of the investigator would jeopardize the evaluation of efficacy or safety
- Persons directly involved in the execution of this protocol
- Pregnant or nursing (lactating) women
- Women of child-bearing potential unless postmenopausal for at least one year, surgically sterile or using effective methods of contraception as defined by local Health Authorities
Participating Mayo Clinic locations
Study statuses change often. Please contact us for help.
|Mayo Clinic Location
Mayo Clinic principal investigator
Amir Lerman, M.D.
Closed for enrollment