Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-25 @ 2:03 AM
NCT ID:
NCT01934660
Eligibility Criteria:
* Cardiovascular Disease Eligibility Criteria
INCLUSION CRITERIA:
* Females and males 18 years of age or older
* Diagnosis of clinical CAD (including abnormal EKG with a prior infarction pattern, abnormal echo consistent with a wall motion abnormality or a referral note from cardiologist with diagnosis of CAD)
* CAD that is currently stable (defined by no change in medications for blood pressure, angina or diuretic therapy or in no new CV symptoms over the past month in a patient who has had a primary cardiac event or an abnormal EKG with confirmed wall motion abnormality)
* CAD which may be associated with chronic stable angina (defined by a clinical syndrome characterized by discomfort in the chest, jaw, shoulder, back, or arm by a physician).
* CAD that is found on CCTA which may be subclinical
EXCLUSION CRITERIA:
* Pregnant women or lactating women.
* For optional adipose biopsy, any subject with known bleeding disorder, current fever or on anti-coagulation.
* For optional MRI, inability to participate due to metal within body, claustrophobia, or anything else that prohibits undergoing a MRI scan
* Any solid organ or liquid tumor within the past five years, with the exception of nonmelanomatous skin cancer,
* Active infectious diseases within 3 months requiring antibiotics, collagen vascular diseases such as RA, psoriasis and mixed connective tissue diseases and immune-mediated lung diseases (e.g. IPF, BOOP)
* A BMI \>40 kg/m(2) due to PET MRI restrictions
* Subjects with severe renal excretory dysfunction, estimated glomerular filtration rate \< 30 mL/min/1.73m(2) body surface area according to the Modification of Diet in Renal Disease criteria, will not receive the cardiac CT angiography, or gadolinium contrast agent during the PET/MRI.
Diabetes Mellitus Eligibility Criteria
INCLUSION CRITERIA:
* Females and males 18 years of age or older
* Diagnosis of type 2 diabetes mellitus (DM), currently stable as defined by no change in antidiabetic medications over the past month and fasting glucose \<200
EXCLUSION CRITERIA:
* Pregnant women and or lactating women.
* For optional adipose biopsy, any subject with known bleeding disorder, current fever or on anti-coagulation.
* For optional MRI, inability to participate due to metal within body, claustrophobia, or anything else that prohibits undergoing a MRI scan
* Any solid organ or liquid tumor within the past five years, with the exception of nonmelanomatous skin cancer,
* Active infectious diseases within 3 months requiring antibiotics, collagen vascular diseases such as RA, psoriasis and mixed connective tissue diseases and immune-mediated lung diseases (e.g. IPF, BOOP)
* A BMI \>40 kg/m(2) due to PET MRI restrictions
* Subjects with severe renal excretory dysfunction, estimated glomerular filtration rate \< 30 mL/min/1.73m(2) body surface area according to the Modification of Diet in Renal Disease criteria, will not receive the cardiac CT angiography, or gadolinium contrast agent during the PET/MRI.
* Subjects with second -or third-degree AV block or sinus node dysfunction will not receive the 13N-ammonia PET/CT imaging unless these patients have a functioning artificial pacemaker.
* Subjects with any signs or symptoms of acute coronary syndrome, including vasoreactive hypertension with blood pressure exceeding 180/100, any concerning ST segment changes on ECG, or acute chest pain, will not receive the 13N-ammonia PET/CT imaging.
Healthy Volunteers:
INCLUSION CRITERIA:
-Females and males 18 years of age or older without any clinical diagnosis of a chronic health condition that is knownto accelerate vascular disease beyond traditional risk factors including lung disease or active infection
EXCLUSION CRITERIA:
* For imaging studies, pregnant women
* For imaging studies, lactating women
* For optional MRI, inability to participate due to in optional MRI metal within body, claustrophobia, or anything else that prohibits undergoing a MRI scan
* Any solid organ or liquid tumor within the past five years, with the exception of non melanomatous skin cancer,
* Active infectious diseases within 3 months requiring antibiotics, collagen vascular diseases such as RA, psoriasis and mixed connective tissue diseases and immune-mediated lung diseases (e.g. IPF, BOOP)
* Clinical diagnosis of diabetes or cardiovascular disease
* Fasting glucose \>125,
* LDL\>200,
* LFT s 3 times normal limit,
* eGFR\<60,
* Subjects with severe renal excretory dysfunction will not receive the cardiac CT angiography, or gadolinium contrast agent during the PET/MRI.
* A BMI \>40 kg/m(2) due to PET MRI restrictions.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT01934660
Study Brief:
Protocol Section:
NCT01934660