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 @ 3:04 PM
Ignite Modification Date:
2025-12-24 @ 3:04 PM
NCT ID:
NCT02045459
Eligibility Criteria:
Inclusion Criteria:
* Age 18 - 85
* Anginal symptoms of chest pain, dyspnea on exertion, or other anginal equivalent suspected to be secondary to myocardial ischemia
* Coronary angiogram without obstructive epicardial coronary artery disease (≥50% epicardial stenosis or fractional flow reserve of \<0.80) within 6 months prior to enrollment or date of CMR #1, whichever is later and without intervening signs or symptoms suggestive of new obstructive epicardial CAD.
Exclusion Criteria:
* Prior CABG (due to limitations of CMR quantitative perfusion in this population)
* Prior myocardial infarction (due to its effects on myocardial flow reserve)
* Hypertrophic or restrictive cardiomyopathy
* Coronary vasospasm
* Acute coronary syndrome unless concurrent coronary angiography reveals no epicardial stenoses of \>50%
* Contraindications to CMR including - intracranial aneurysm clips, implantable pacemaker or defibrillator, metal cochlear/intraocular implants, any metallic implant not listed as magnetic resonance compatible, severe claustrophobia or other inability to tolerate a 30 minute CMR study
* GFR \< 45 ml/min/1.73² (to avoid nephrogenic systemic fibrosis and iodinated contrast dye - mediated ATN) based on creatinine within 30 days of CMR #1
* Acute kidney injury, defined by the KDIGO Clinical Practice Guidelines as an increase in serum creatinine of ≥0.3 mg/dL within 48 hours, an increase in serum creatinine ≥1.5 times baseline thought to have occurred in the past 7 days, or a urine volume \<0.5mL/kg/h for 6 hours
* Severe liver disease, paraproteinemia syndromes (such as multiple myeloma), hepatorenal syndrome, or planned liver transplantation (gadolinium contraindication)
* Pregnancy (assessed by serum beta- HCG prior to CMR) due to unclear gadolinium fetal effects
* Known hypersensitivity to regadenoson, or gadolinium
* Other contraindications to regadenoson (heart rate \< 40 bpm, 2nd or 3rd degree heart block, sick sinus syndrome without a pacemaker, severe asthma or COPD with ongoing wheezing or hospitalization within the past 6 months, systolic blood pressure \<90mmHg, recent use of dipyridamole, methylxanthine (such as aminophylline) or dipyridamole use within the past 48 hours, or caffeine within 12 hours)
* Atrial fibrillation with rapid ventricular response, frequent ectopy, or other contraindications to ECG gating
* Inability to provide informed consent
* Life expectancy of \< 2 years
3\. List any restrictions on use of other drugs or treatments.
* Subject will be asked to refrain from use of caffeine for 12 hours and methylxanthines and dipyridamole for 48 hours prior to any administration of regadenoson. Subject may not participate if pregnant or breastfeeding.
Phase 2:
1. List the criteria for inclusion
* Enrollment in phase #1.
* MPR \<2.0 ml/g/min on CMR #1.
2. List the criteria for exclusion
•Unable to exercise.
3. List any restrictions on use of other drugs or treatments. Subject will be asked to refrain from use of caffeine for 12 hours and methylxanthines and dipyridamole for 48 hours prior to any administration of regadenoson. Subject may not participate if pregnant or breastfeeding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT02045459
Study Brief:
Protocol Section:
NCT02045459