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:
2025-12-24 @ 2:23 PM
Ignite Modification Date:
2025-12-24 @ 2:23 PM
NCT ID:
NCT01754259
Eligibility Criteria:
Inclusion Criteria
1. type 1 or 2 diabetes mellitus
2. anginal symptoms and/or exertional dyspnea;
3. ability to exercise and achieve an exercise tolerance of at least 3 METS but not higher than 9 METS either on a treadmill or bicycle exercise tolerance test;
4. perfusion sum stress score (SSS) ≤ 6, as assessed by initial PET
Exclusion Criteria
1. patients not fulfilling inclusion criteria
2. patients with evidence of unprotected left main coronary artery stenosis \>50%
3. patients with evidence of new obstructive CAD not on optimal medical therapy
4. evidence of angiographic disease and/or inducible myocardial ischemia on stress testing planning to undergo revascularization within the following 3 months
5. history of cardiomyopathy (LVEF \<40%) or significant valvular heart disease
6. uncontrolled hypertension (SBP \>180 mm Hg at screening)
7. gait instability, lower extremity amputations preventing exercise
9\. significant liver dysfunction (LFTs \>3x upper limits of normal), including cirrhosis 10. prolonged QT (QTc \>450 and \>470 ms for men and women, respectively) or concomitant use of drugs that prolong QT interval (including methadone and antiarrhythmics such as sotalol, amiodarone, and quinidine) 11. use of drugs that inhibit CYP3A such as ketoconazole, itraconazole, fluconazole, clarithromycin, erythromycin, diltiazem, verapamil, nefazodone, nelfinavir, ritonavir, lopinavir, ritonavir, indinavir, and saquinavir 12. use of drugs that induce CYP3A such rifampin, rifabutin, rifapentine, phenobarbital, phenytoin, carbamazepine, and St. John's wort 13. atrial fibrillation / inability to hold breath for ≥ 10 seconds (in patients in whom CTA will be performed) 14. eGFR \< 50 ml/min or end stage renal disease on dialysis 15. allergy to intravenous contrast 16. pregnant or lactating women, or women of childbearing potential not using an acceptable form of birth control (negative pregnancy test also required) 17. inability to fit safely in PET/CT scanner
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT01754259
Study Brief:
Protocol Section:
NCT01754259