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 @ 6:26 PM
Ignite Modification Date:
2025-12-24 @ 6:26 PM
NCT ID:
NCT01986868
Eligibility Criteria:
Inclusion Criteria:
* Age ≥18 years
* Ability to comprehend and sign informed consent
* Presence of a non-calcified or mixed plaque without high-grade stenosis in the left main or a proximal coronary artery segment AND at least one APC present in this plaque by CCTA (defined as LAP with \<30 Hounsfield units or PR with ≥10% increase in the maximal vessel diameter within the plaque as compared to a proximal reference segment as previously described10).
Exclusion Criteria:
* High-grade stenosis (≥50% stenosis of the left main artery or ≥70% stenosis of another proximal coronary segment);
* Coronary artery stent in the segment with the reference plaque
* Possible pregnancy
* Glomerular filtration rate \<45 ml/min
* More than 90 days between CCTA and CMRA study
* Any significant arrhythmia (e.g. atrial fibrillation, frequent ectopy)
* Significant asthma
* History of 2nd or 3rd degree heart block
* Allergy or known intolerance to beta-blockers
* Use of phosphodiesterase inhibitor (e.g. Viagra) within the last 48 hours
* Rapid heart rate (heart rate ≥90 beats/minute)
* Severe aortic stenosis (Aortic valve area \<1.0 cm2 or mean gradient \>30 mmHg)
* Systolic blood pressure \<100 mmHg
* Other contraindication to MRI, including metallic implants (valve replacement, pacemaker, implantable cardiac defibrillator, metallic spine material), intracranial clips, metallic fragments in eyes, and claustrophobia
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01986868
Study Brief:
Protocol Section:
NCT01986868