Prediction of Atherosclerotic Plaque Progression
PPP
1 other identifier
observational
40
1 country
1
Brief Summary
To predict coronary atherosclerosis progression in patients with acute coronary syndrome by the use of intracoronary imaging methods. To investigate the ability of NIRS to detect vulnerable plaque characterized by the presence of OCT-defined TCFA To study the influence of gene polymorphisms (in genes playing role in vessel dilatation) on the progression of coronary atherosclerosis and clinical outcomes
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2015
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 15, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 29, 2018
CompletedFirst Submitted
Initial submission to the registry
May 16, 2022
CompletedFirst Posted
Study publicly available on registry
June 21, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2027
ExpectedJune 21, 2022
June 1, 2022
3 years
May 16, 2022
June 15, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Prediction of coronary atherosclerosis progression
Prediction of coronary atherosclerosis progression (assesed by computed tomography, CT) in patients with acute coronary syndrome by the use of intracoronary imaging methods (OCT and NIRS)
Two years from the date of cardiac catheterization
Secondary Outcomes (2)
Detection of vulnerable coronary atherosclerotic plaques by NIRS and OCT
Measured once at the time of cardiac catheterization.
Presence of gene polymorphisms
Analyzed once at the time of cardiac catheterization.
Interventions
Eligibility Criteria
Patients with acute coronary syndrome indicated for coronary angiography with presence of a non-culprit lesion not indicated for revascularization
You may qualify if:
- Acute coronary syndrome diagnosis
- Presence of at least one non-culprit coronary lesion (not indicated for revascularisation)
You may not qualify if:
- Contraindication for OCT or IVUS
- Circulatory instability
- Renal insufficiency (creatinine level \>200umol/l)
- Pregnant or of childbirth age and not using reliable contraception
- Life expectancy of less than one year
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Na Homolce Hospitallead
- Ministry of Health, Czech Republiccollaborator
Study Sites (1)
Na Homolce Hospital
Prague, 15030, Czechia
Biospecimen
Patient DNA will be isolated from peripheral blood leucocytes by standard techniques. Genetic analysis of polymorphisms in gene for Hemoxygenase-1 and endothelial Nitric Oxide Synthase.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D
Study Record Dates
First Submitted
May 16, 2022
First Posted
June 21, 2022
Study Start
January 15, 2015
Primary Completion
January 29, 2018
Study Completion (Estimated)
March 31, 2027
Last Updated
June 21, 2022
Record last verified: 2022-06