CAUSE Trial: Patient Specific-Cellular Characterization of Fibromuscular Dysplasia and High-Risk … (NCT01808729) | Clinical Trial Compass
CompletedNot Applicable
CAUSE Trial: Patient Specific-Cellular Characterization of Fibromuscular Dysplasia and High-Risk Atherosclerotic Endothelium
United States34 participantsStarted 2013-02
Plain-language summary
The purpose of this project is to see if heritable alterations in the function, biology and vascular repair capacity of vascular cells make a major contribution to the burden of coronary artery disease (CAD), fibromuscular dysplasia (FMD), and other vascular diseases.
In more detail, FMD is a nonatherosclerotic vascular disease that primarily affects women aged 20 to 60. It commonly affects the renal and carotid arteries but may involve almost every artery in the body. At the cellular level, FMD is characterized by increased fibroblast proliferation and collagen deposition. This study aims to define some of these cellular problems by directly studying fibroblast cells from FMD patients and healthy control subjects. Similarly, CAD is among the leading causes of death worldwide. However, a large part of the risk for CAD is unexplained. It is thought that a major but undefined risk factor may be gene (genomic) variations causing a change in vascular cell function. Here, we will study important vascular cell types in patients with severe and early onset CAD in an attempt to define these problems. Therefore, in summary, this study will look to define the various cellular-level problems that occur in patients with both in CAD and FMD. These data will be linked to DNA-level analyses to ultimately attempt to define the cause of these conditions.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Clinical diagnosis of FMD based on current guideline criteria and relevant imaging results.
* For ET-CAD (early onset CAD) = patients \<50 years of age for males and \<55 for females with \>60% stenosis in ≥2 coronary arteries or their branches, or SYNTAX score ≥12 (significant CAD), in the absence of acquired CAD risk factors.
* Patients with \>60% stenosis in ≥2 coronary arteries or their branches, or SYNTAX score ≥12, will also be eligible for the ET-CAD group as follows: a) \<40 years of age for males and \<45 for females in the presence of one acquired risk factor; b) \<35 years of age for males or females and two acquired risk factors.
* Patients already having undergone revascularization will be eligible if other criteria are fulfilled and an aggregate SYNTAX score of ≥12 would have been reached for all treated lesions, or there was disease in ≥2 coronary arteries or their branches, according to the criteria (1) and (2) above.
* For Healthy Controls = age matched patients who have undergone angiography and who do not have CAD ('normal coronary arteries'; SYNTAX score = 0) but with ≥2 acquired CAD risk factors. Control subjects for the FMD studies will be unaffected family members, or unrelated persons matched for age and gender.
* For all subjects, other inclusion criteria are:
* a. Age \>18 years;
* b. Fluency in English or Spanish (Spanish consent forms will be provided);
* c. Freely willing to participate with signed informed consent.
* Acquir…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Phenotypic cellular differences (fibroblasts and/or ps-iPSC-ECs) between cases and controls