STUDY TITLE: HYBRID REVASCULARIZATION OBSERVATIONAL STUDY (COHORT 1 & 2)
CURRENT STATUS: Enrollment Complete
What is the purpose of this research?
The purpose of the study is to get a better understanding of patients who have multi-vessel coronary artery disease (blockages in more than one vessel bringing blood to the heart) and have either Hybrid Coronary Revascularization [HCR] (combination of surgery and catheter procedures to open up clogged heart arteries) or Percutaneous Coronary Intervention [PCI] (catheter procedures to open up clogged heart arteries). The study will collect information about the medical care you receive during your planned procedure(s) and how well you do following the procedure(s). No new testing or procedures will be done. You will receive only the tests or procedures your doctor already has planned for you. We call this kind of study an “observational study” because all we plan to do is observe the care you receive and how well you do during and after your treatment. The information we collect should help us to improve the quality of heart care in the future.
Why is this Study Necessary?
Currently, the available evidence addressing this issue is limited. Collecting information about patients who receive HCR or PCI at different hospitals helps us learn what treatment measures work best for patients with multi-vessel coronary artery disease. The results of this observational study may be used by researchers for 5 years to design a planned experiment, in which we would study what approach and management practices would be best to ensure that all patients with your condition will get the best procedure.
Who can be in this study?
Patients who have multi-vessel coronary artery disease (blockages in more than one vessel bringing blood to the heart) and have either Hybrid Coronary Revascularization [HCR] (combination of surgery and catheter procedures to open up clogged heart arteries) or Percutaneous Coronary Intervention [PCI] (catheter procedures to open up clogged heart arteries) can participate in this study.
Who cannot be in this study?
Patients who are not undergoing either Hybrid Coronary Revascularization [HCR] or Percutaneous Coronary Intervention [PCI] cannot participate in this study.
What procedures will be followed?
The study will proceed in the following stages once you have agreed to participate.
Baseline and Pre-Discharge Data Collection
If you are eligible to participate, we will collect information about the care that you receive during your hospitalization. This includes your demographics, medical history, and information about your heart procedure(s) and hospital stay. A copy of your catheterization film (pictures of your heart) will be sent to a data coordinating center at Mount Sinai School of Medicine (New York) for further analysis. All of the information collected will be coded by labeling them with your unique identification code.
Follow-up Phone Calls
After you are discharged from the hospital, all patients who receive HCR or PCI will receive a telephone follow-up call at 6, 12, 18, and 21 months. During these calls, you will be asked if you have experienced any complications or have had heart surgery or heart procedures since you were discharged from the hospital. A participant may choose to skip any question that she or he would prefer not to answer. All data that are collected prior to, during, and after the surgery will be sent to a data coordinating center at Mount Sinai School of Medicine (New York) for storage and analysis.
What are the possible risks of being in this study?
Because we will only be observing your care and not giving you any new treatments or tests, there are no additional discomforts from participating. The health risks related to the heart surgery or procedure(s) are the same for you whether you participate in the study or not.
Loss of confidentiality
A risk of taking part in this study is the possibility of a loss of confidentiality. Loss of confidentiality includes having your personal information shared with someone who is not on the study team and was not supposed to see or know about your information. The study team plans to protect your confidentiality. This risk is small because we have put in place a number of protections to prevent this from occurring.
What are the possible benefits of being in this study?
You will not receive direct benefit from this study. Your participation may increase knowledge about the best ways to treat patients who have multi-vessel heart disease which may help other patients with multi-vessel heart disease in the future.
How long will I be in the study?
Your participation in this study will be limited. Routine medical information will be obtained from your medical chart. A study nurse will schedule 4 phone calls with you, each lasting 10 minutes at 6, 12, 18, and 21 months after surgery. If you come to the hospital for a scheduled office visit, the phone call may not be needed if you prefer to provide this information in person. During the phone call, you will be asked if you have experienced any complications after your surgery.
What are the costs to be in this study?
Taking part in this study will not involve additional costs to you. You will still be responsible for your usual medical costs.
Who is funding this research?
This research is being supported by a research grant from the following government programs:
• National Heart, Lung, and Blood Institute (NHLBI)
• National Institute of Neurological Disorders and Stroke (NINDS)
• Canadian Institutes of Health Research (CIHR)
For Further Information about the Study and Enrollment
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, NCT Trial number, NCT01121263, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.
For any additional questions, you may send an email to the Mount Sinai Data Coordinating Center:
• Ellen Moquete, RN, BSN, firstname.lastname@example.org, 212-659-9651 or
• Karen O’Sullivan, MPH, email@example.com, 212-659-9720
IRB approved through 3/18/15