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Role of Intracoronary Imaging in Plaque Identification

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ClinicalTrials.gov Identifier: NCT03953040
Recruitment Status : Recruiting
First Posted : May 16, 2019
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
Ayat Aboutaleb Abdellah Abdelgalil, Assiut University

Brief Summary:
NSTE-ACS patients are more likely to exhibit high-risk plaque characteristics in non-culprit lesions. Both IVUS and OCT imaging techniques interact in a complementary manner to provide morphological characterization of the atherosclerotic coronary plaques and help identification of high-risk vulnerable plaques. Using morphological parameters obtained from OCT and IVUS, a new plaque vulnerability score will be established for more precise definition of the most vulnerable plaques that carry the greatest risk of rupture and subsequent detrimental clinical outcomes in the future. Such score might help in targeting these plaques with certain therapeutic interventions aiming to their stabilization.

Condition or disease Intervention/treatment
Coronary Artery Disease Diagnostic Test: intracoronary imaging (IVUS, OCT)

Detailed Description:
Patients with NSTE-ACS presented to the study site fulfilling the eligibility criteria during enrollment period of 1 year. The culprit lesion(s) being responsible for the acute event will be revascularized by percutaneous coronary intervention (PCI). Both OCT (OPTISTM, St. Jude Medical Inc., St. Paul, MN, USA) and IVUS (Boston Scientific iLabTM Ultrasound Imaging System, MA, USA) will be performed after PCI to examine the non-culprit lesion(s) for detection of atherosclerotic plaques with the morphological characteristics consistent with high-risk plaques, namely "Vulnerable plaques". Plaque characteristics from IVUS and OCT imaging will be merged to establish novel scores, which help improve diagnostic accuracy for detection of high-risk lesions. Correlations IVUS and OCT images will be performed to identify most reliable factors associated with plaque vulnerability.Patients will be followed up to 6 months after PCI for detection of major adverse cardiovascular outcomes (MACE) after ischaemia-driven revascularization of the culprit lesion(s).

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Study Type : Observational
Estimated Enrollment : 35 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Integrated Role of Intravascular Ultrasound and Optical Coherence Tomography to Define a New Plaque Vulnerability Score: A Pilot Study in Non STE-ACS
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : March 1, 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: intracoronary imaging (IVUS, OCT)
    Patients presenting with non STE-ACS will be subjected after performing PCI of the culprit lesion to intracoronary imaging with the help of IVUS and OCT of the non-culprit lesions to detect and image the so-called vulnerable plaques


Primary Outcome Measures :
  1. Establishment of a new plaque vulnerability score to define vulnerable plaques by IVUS and OCT imaging. [ Time Frame: 1 year-duration ]
    IVUS and OCT Images will be examined for any identified atherosclerotic plaque.


Secondary Outcome Measures :
  1. Hypothesis generation that could correlate this new plaque vulnerability score with the clinical outcomes after the follow up period. [ Time Frame: 6 months ]
    Clinical outcomes in form of MACE



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   18 years and more
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The study subjects are patients with history of non-ST elevation acute coronary syndrome (NSTE-ACS):

• *Diagnosis of NSTE-ACS: history of prolonged anginal pain (more 20 min) at rest, or recent instability of previously stable angina pectoris (at least Canadian Society Cardiovascular angina class III), or post-MI angina, together with ST segment or T wave changes. According to the results of cardiac biomarker, NSTE-ACS is subdivided into: NSTEMI (with +ve cardiac biomarkers) and unstable angina (with -ve cardiac biomarkers).

Criteria

Inclusion Criteria:1.Provided written informed consent prior to initiation of the study.

2. Age ≥18 years at time of enrollment. 3. History of NSTE-ACS being within a period not more than 1-2 months with an indication for invasive coronary angiography with interventional treatment of culprit lesion(s).

- 4. Meet all the following angiographic criteria on the qualifying coronary angiogram (CA):

  1. Angiographic evidence of coronary artery disease (CAD) with ≥20% reduction of the luminal diameter by visual estimation on CA, in addition to the culprit lesion(s).
  2. In case of left main coronary artery; there must be a <50% reduction in the lumen diameter by visual estimation on CA.
  3. Target vessel:

(i) May not be the culprit vessel for the current or a previous myocardial infarction.

(ii) De novo (new onset) target lesion (at least one) with luminal stenosis up to 50% by visual estimation on CA but not more than 50% and not responsible for the acute event (i.e., nonculprit).

(iii) Targeted segment must be at least 40 mm in length.

Exclusion Criteria:1. General exclusion criteria: malignancy, chronic debilitating diseases, hepatic cell failure, COPD, and life expectancy < 2years. 2. Chronic renal insufficiency: an estimated glomerular filtration rate (eGFR) < 30ml/min/1.73m2 (safety issues with excess contrast used with OCT imaging). 3. Patients with hemodynamic instability i.e., in cardiogenic shock. ▪ Angiographic exclusion criteria: 4. Patients with previous percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) in the non-culprit lesion(s). 5. Marked tortuosity or heavy calcification that preclude a safe advancement of OCT or IVUS system.

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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): NCT03953040


Contacts
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Contact: Ayat A. Abdelgalil, Msc. +2 01144478313 soze2080@gmail.com
Contact: Hatem A. Helmy, MD +2 01005212162 hatem19652007@yahoo.com

Locations
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Germany
Deutsches Herzzentrum Recruiting
München, Bavaria, Germany, 80636
Contact: Ayat A. Abdelgalil, Msc.    +49 01774216015    soze2080@gmail.com   
Contact: Michael Joner, MD       joner@dhm.mhn.de   
Sponsors and Collaborators
Assiut University
Investigators
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Study Director: Amr A. Amr, MD Assiut University

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Responsible Party: Ayat Aboutaleb Abdellah Abdelgalil, Assistant lecturer, Assiut University
ClinicalTrials.gov Identifier: NCT03953040     History of Changes
Other Study ID Numbers: OCTIVUS2019
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases