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Coronary Plaque Geometry and Acute Coronary Syndromes

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ClinicalTrials.gov Identifier: NCT03702764
Recruitment Status : Recruiting
First Posted : October 11, 2018
Last Update Posted : March 15, 2019
Sponsor:
Collaborators:
University of Targu Mures, Romania
University Hospital of Targu Mures, Romania
Information provided by (Responsible Party):
Cardio Med Medical Center

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.

Condition or disease Intervention/treatment
Coronary Stenosis Acute Coronary Syndrome Acute Myocardial Infarction Atherosclerosis Atheromatous Plaques Diagnostic Test: CCTA

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Definition: Impact of Coronary Plaque Geometry on Plaque Vulnerability and Their Association With the Risk of Future Cardiovascular Events in Patients With Chest Pain Undergoing Coronary Computed Tomographic Angiography - the GEOMETRY STUDY
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : November 30, 2021

Group/Cohort Intervention/treatment
VP-SG 01
Study subjects that present concentric coronary plaques
Diagnostic Test: CCTA
128-multislice CT coronary angiography and complex atherosclerotic plaque analysis, with the use of CT imaging post-processing techniques.

VP-SG 02
Study subjects that present eccentric coronary plaques
Diagnostic Test: CCTA
128-multislice CT coronary angiography and complex atherosclerotic plaque analysis, with the use of CT imaging post-processing techniques.




Primary Outcome Measures :
  1. Major adverse cardiovascular events [ Time Frame: Month 24 ]
    Incidence of MACE during follow-up


Secondary Outcome Measures :
  1. Coronary plaque vulnerability associated to plaque eccentricity [ Time Frame: Month 24 ]
    Number of vulnerability markers in eccentric vs concentric plaques



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03702764


Contacts
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Contact: Mihaela Ratiu, MD +40741620363 d_a_mihaela@yahoo.com
Contact: Theodora Benedek, Professor theodora.benedek@gmail.com

Locations
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Romania
Cardio Med Medical Center Recruiting
Târgu-Mureş, Mures, Romania, 540102
Contact: Mihaela Ratiu, MD    +40741620363    d_a_mihaela@yahoo.com   
Contact: Theodora Benedek, Professor       theodora.benedek@gmail.com   
Sponsors and Collaborators
Cardio Med Medical Center
University of Targu Mures, Romania
University Hospital of Targu Mures, Romania

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Responsible Party: Cardio Med Medical Center
ClinicalTrials.gov Identifier: NCT03702764     History of Changes
Other Study ID Numbers: CM0218-GEO
First Posted: October 11, 2018    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: January 2019
Keywords provided by Cardio Med Medical Center:
coronary plaque eccentricity
vulnerable coronary plaque
coronary artery disease
myocardial infarction
coronary computed tomography angiography
major adverse cardiac events
Additional relevant MeSH terms:
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Myocardial Infarction
Atherosclerosis
Acute Coronary Syndrome
Coronary Stenosis
Syndrome
Infarction
Plaque, Atherosclerotic
Disease
Pathologic Processes
Ischemia
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Pathological Conditions, Anatomical
Arteriosclerosis
Arterial Occlusive Diseases
Coronary Disease