CompletedNot Applicable

Coronary Plaque Geometry and Acute Coronary Syndromes

Romania1,000 participantsStarted 2019-02-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients with suspected coronary artery disease (CAD) and pre-test probability of CAD between 15% and 85%, who undergo CCTA, and in whom CCTA has identified presence of at least one coronary plaque * Ability to provide informed consent * Age grater then 18 years Exclusion Criteria: * Patients with pre-test probability of CAD \>85% or \<15% * Electrocardiographic evidence of STEMI * Presence of pre-existing CAD including prior myocardial infarction * History of coronary artery revascularization (by percutaneous coronary intervention, stent or bypass graft surgery) * Atrial fibrillation or other irregular rhythm * Unwillingness or incapacity to provide informed consent * Allergy to iodine contrast media * Inability to tolerate beta-blocker medication * Renal insufficiency (creatinine greater than 1.5 mg/dL) or renal failure requiring dialysis * Pregnant women or lactation * Active malignancy or malignancy within the last 5 year prior to enrolment * Conditions associated with an estimated life expectancy of under 2 years * Coronary calcium score \>1000

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Major adverse cardiovascular events

Timeframe: Month 24

Trial details

NCT IDNCT03702764

SponsorCardio Med Medical Center

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2019-11-30

View on ClinicalTrials.gov More Coronary Stenosis trials