Status:
COMPLETED
CAUSE Trial: Patient Specific-Cellular Characterization of Fibromuscular Dysplasia and High-Risk Atherosclerotic Endothelium
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Conditions:
Fibromuscular Dysplasia
Early Onset CAD
Eligibility:
All Genders
18+ years
Brief 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 diseas...
Detailed Description
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 diseas...
Eligibility Criteria
Inclusion
- 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.
- Acquired Risk Factors are defined as:
- (1) Diabetes for \>2 years or HBA1C \>10.0%;
- (2) Smoker of \>5 pack-years for entire lifetime;
- (3) Obesity (BMI \>30kg/m2);
- (4) Dyslipidemia, defined by use of lipid lowering therapy, physician diagnosis of dyslipidemia, serum total cholesterol \>240 mg/dL or low-density lipoprotein-cholesterol \>100 mg/dL;
- (5) Hypertension according to guidelines or requiring therapy.
Exclusion
- Smoking \>2 packets of cigarettes/day for \>12 months;
- Prior total cholesterol level of \>400mg/dl;
- BMI \>40 kg/m2;
- Uncontrolled or severe diabetes with prior hospitalization due to diabetic complications other than at diagnosis;
- For ET-CAD patients: Uncontrolled or severe hypertension causing hospitalization or direct complications;
- Serum creatinine ≥2.0 mg/dL;
- Heart transplantation;
- Active autoimmune disease;
- Illicit drug use;
- HIV positive;
- Prior malignancy with mediastinal irradiation, bone marrow transplantation or high-dose chemotherapy;
- Adult congenital heart disease;
- For healthy controls only, a positive family history of CAD or FMD.
- Also, as an extension of this study, patients presenting with rare, undiagnosed or unusual forms of CAD (e.g. unexplained dissection, fulminant calcification, aneurysms etc.) and FMD and appropriate controls, will be recruited, particularly if there is a strong family pedigree.
Key Trial Info
Start Date :
February 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT01808729
Start Date
February 1 2013
End Date
October 1 2013
Last Update
November 5 2013
Active Locations (1)
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1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029