NCT03702764

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

October 8, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 11, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
Last Updated

August 2, 2022

Status Verified

July 1, 2021

Enrollment Period

10 months

First QC Date

October 8, 2018

Last Update Submit

July 30, 2022

Conditions

Coronary StenosisAcute Coronary SyndromeAcute Myocardial InfarctionAtherosclerosisAtheromatous Plaques

Keywords

coronary plaque eccentricityvulnerable coronary plaquecoronary artery diseasemyocardial infarctioncoronary computed tomography angiographymajor adverse cardiac events

Outcome Measures

Primary Outcomes (1)

  • Major adverse cardiovascular events

    Incidence of MACE during follow-up

    Month 24

Secondary Outcomes (1)

  • Coronary plaque vulnerability associated to plaque eccentricity

    Month 24

Study Arms (2)

VP-SG 01

Study subjects that present concentric coronary plaques

Diagnostic Test: CCTA

VP-SG 02

Study subjects that present eccentric coronary plaques

Diagnostic Test: CCTA

Interventions

CCTADIAGNOSTIC_TEST

128-multislice CT coronary angiography and complex atherosclerotic plaque analysis, with the use of CT imaging post-processing techniques.

VP-SG 01VP-SG 02

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study population includes patients from a single center with suspected coronary artery disease, meeting inclusion and exclusion criteria and undergoing CCTA by physician referral for coronary luminal evaluation.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardio Med Medical Center

Târgu Mureş, Mureș County, 540102, Romania

Location

MeSH Terms

Conditions

Coronary StenosisAcute Coronary SyndromeAtherosclerosisPlaque, AtheroscleroticCoronary Artery DiseaseMyocardial InfarctionCardiovascular Diseases

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesVascular DiseasesArteriosclerosisArterial Occlusive DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsInfarctionIschemiaPathologic ProcessesNecrosis

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2018

First Posted

October 11, 2018

Study Start

February 1, 2019

Primary Completion

November 30, 2019

Study Completion

November 30, 2021

Last Updated

August 2, 2022

Record last verified: 2021-07

Locations

RO(1)