Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03702764 |
| Other study ID # |
CM0218-GEO |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2019 |
| Est. completion date |
November 30, 2021 |
Study information
| Verified date |
July 2021 |
| Source |
Cardio Med Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The aim of GEOMETRY study is to investigate the correlation between coronary plaque geometric
modifications and lesion vulnerability in patients with suspected coronary artery disease
referred for cardiac computed tomography angiography (CCTA). Furthermore the study will
evaluate the impact of plaque eccentricity and morphology on the rate of major adverse
cardiovascular events (MACE) for a 2 years follow-up period.
Description:
Coronary artery disease (CAD) remains the leading cause of mortality and morbidity worldwide.
Early detection of CAD may reduce the incidence of myocardial infarction by improving primary
prevention and providing more effective treatment methods. A step in this direction is
identifying the pattern of coronary plaques which are prone to rupture. Coronary computed
tomography angiography (CCTA) has emerged recently as a reliable noninvasive tool used in the
evaluation of coronary arteries. Some features related to plaque composition and morphology
such as low attenuation plaques, spotty calcification, positive remodeling or napkin ring
sign, were already identified as vulnerability markers. However the role of lesion geometry
on plaque vulnerability was not investigated yet.
This is a prospective, cohort, single-center study which will be carried out in the Center of
Advanced Research in Multimodal Cardiac Imaging Cardiomed.
The study will include 1.000 subjects with suspected CAD who are referred to CCTA by the
attending physician and in which presence of at least one coronary plaque is confirmed by
CCTA.
Plaque burden, composition, and morphology will be assessed for each plaque. Longitudinal and
transversal eccentricity will be also assessed in each plaque and in all cases, eccentricity
index will be calculated in cross-section plane at the degree of maximum stenosis in order to
determine the position of the remaining circulant lumen and to classify the plaque into
concentric and eccentric lesion.
The study will be conducted over a period of 3 years, in which patients will be examined at
baseline, and will be followed-up for 2 years for occurrence of MACE.
Study objectives:
Primary: to evaluate the association between different patterns of plaque geometry and the
risk for major adverse cardiac events MACE (all-cause mortality, cardiovascular death,
myocardial infarction, repeated revascularization, repeated hospitalizations for
cardiovascular related incidents, cerebrovascular events) during a 2-year follow-up,
Secondary: to evaluate the association of plaque eccentricity, plaque vulnerability and
plaque progression after 2 years of follow-up
Study Timeline:
- Baseline (day 0)
- Obtain and document consent from participant on study consent form.
- Verify inclusion/exclusion criteria.
- Obtain demographic information, medical history, medication history, alcohol and
tobacco use history.
- Record results of physical examinations and 12-lead ECG.
- Collect blood specimens.
- Imaging: 128-multislice CT angiography.
- Visit 1 (month 6)
- Record results of physical examinations, 12-lead ECG and medical history.
- MACE assessment
- Visit 2 (month 12)
- Record results of physical examinations, 12-lead ECG and medical history.
- MACE assessment
- Visit 3 (month 18)
- Record results of physical examinations, 12-lead ECG and medical history.
- MACE assessment
- Final study visit (month 24)
- Record results of physical examinations, 12-lead ECG and medical history.
- Repeat CCTA and plaque assessment
- End-point evaluation.
Study procedures:
- Medical history, clinical examination, laboratory tests;
- 12-lead ECG
- 128-multislice CT coronary angiography with the evaluation of: calcium score, plaque
burden, markers for lesion severity (degree of stenosis, lesion length, lumen area and
diameter, minimum and maximum plaque thickness); morphological plaque characteristics
(plaque related volumes, plaque burden, remodeling indexes); shear stress by
computational fluid dynamics; markers of plaque vulnerability (low attenuation plaque,
spotty calcification, positive remodeling, napkin ring sign); plaque geometry by
eccentricity index, longitudinal and transversal eccentricity.
