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Optical Coherence Tomography Assessment of Gender diVersity In Primary Angioplasty: The OCTAVIA Trial (OCTAVIA)

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ClinicalTrials.gov Identifier: NCT02577965
Recruitment Status : Completed
First Posted : October 16, 2015
Last Update Posted : October 16, 2015
Sponsor:
Collaborator:
Light Lab Imaging, Inc.
Information provided by (Responsible Party):
GGuagliumi, A.O. Ospedale Papa Giovanni XXIII

Brief Summary:

Recent studies suggest important gender differences in the pathophysiology and prognosis of ST-segment elevation myocardial infarction (STEMI). This is the first prospective controlled study to assess gender differences in the mechanism of plaque rupture/erosion and thrombus formation in patients presenting with STEMI treated with primary angioplasty. Gender-related mechanisms of plaque rupture or erosion will be investigated using a combination of Quantitative Coronary Angiography (QCA), high resolution Optical Coherence Tomography (OCT) of the culprit vessel and histopathology analyses of thrombus aspirates of the infarct related lesion, performed by independent core laboratories, blinded to group (male or female) and clinical variables.

In OCTAVIA; enrollment in a 1:1 ratio according to gender group will be ensured by a computer-assisted matching algorithm for gender and age (< 50, 51-70, and > 70 years). Matching has the purpose to enable enrollment of an even number of male and female patients in balanced age groups. This type of dynamic algorithm is appropriate when the composition of the referral population is not known in advance.

The sample size for the OCTAVIA study was calculated on the basis of per patient stent strut coverage (a continuous variable with right skewed distribution) with mean of 97.0% and standard deviation of 4.0% in men, versus mean of 95.0% and standard deviation of 4.0% in women, following XIENCE PRIME™ Everolimus Eluting Coronary Stent System implantation. Thus, aiming for a 5% 2-tailed superiority alpha, an 80% power, and assuming a 1:1 enrollment according to gender, a total of 64 patients per group should be enrolled. Anticipating a 10% dropout rate due to patients lost to follow-up and inadequate imaging (included major side branch sections), the total enrollment is set at 70 patients per group (total population of 140 subjects).


Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Procedure: Percutaneous Coronary Intervention Device: XIENCE PRIME Everolimus Eluting Coronary Stent System Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Optical Coherence Tomography Assessment of Gender diVersity In Primary Angioplasty: The OCTAVIA Trial
Study Start Date : March 2011
Actual Primary Completion Date : June 2012
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Everolimus

Arm Intervention/treatment
Experimental: Female Arm
Female gender diagnosed with ST segment Elevation Myocardial Infarction (STEMI). Interventions: Angiography, thrombus aspiration, optical coherence tomography and percutaneous coronary intervention, implantation of XIENCE PRIME Everolimus Eluting Coronary Stent. Angiography and Optical Coherence Tomography follow up at 9 months.
Procedure: Percutaneous Coronary Intervention
Thrombus aspiration and histopathological analysis ,Optical Coherence Tomography assessment of culprit vessel during primary PCI, Primary PCI and Drug Eluting Stent (DES) - XIENCE PRIME Everolimus Eluting Coronary Stent implantation in culprit lesion, coronary angiography and OCT assessment at 9 months follow-up

Device: XIENCE PRIME Everolimus Eluting Coronary Stent System
Xience Prime Everolimus Eluting Coronary Stent System implantation to treat Acute Myocardial Infarction

Active Comparator: Male Arm
Male Gender with diagnose of ST segment Elevation Acute Myocardial Infarction (STEMI). Interventions: Angiography, thrombus aspiration, optical coherence tomography and percutaneous coronary intervention, implantation of XIENCE PRIME Everolimus Eluting Coronary Stent. Angiography and Optical Coherence Tomography follow up at 9 months.
Procedure: Percutaneous Coronary Intervention
Thrombus aspiration and histopathological analysis ,Optical Coherence Tomography assessment of culprit vessel during primary PCI, Primary PCI and Drug Eluting Stent (DES) - XIENCE PRIME Everolimus Eluting Coronary Stent implantation in culprit lesion, coronary angiography and OCT assessment at 9 months follow-up

Device: XIENCE PRIME Everolimus Eluting Coronary Stent System
Xience Prime Everolimus Eluting Coronary Stent System implantation to treat Acute Myocardial Infarction




Primary Outcome Measures :
  1. percentage of ruptured or eroded plaques at infarct related lesion as assessed by OCT before PCI [ Time Frame: within 6 hours from symptoms onset ]
    To assess gender differences in the percentage of ruptured or eroded plaques at infarct related lesion as assessed by OCT before PCI.


Secondary Outcome Measures :
  1. Minimal Fibrous Cap Thickness (µm) at infarct-related lesion. [ Time Frame: within 6 hours from symptoms onset ]
    To assess gender differences in Minimal Fibrous Cap Thickness at infarct related lesion.

  2. Presence and type of thrombus at culprit site [ Time Frame: within 6 hours from symptoms onset ]
    To assess gender differences in thrombus type at culprit site

  3. Number of Thin Cat Fibroatheroma (TCFA) (<65 µM) in the scanned segment. [ Time Frame: within 6 hours from symptoms onset ]
    To assess gender difference in TCFA number in culprit site

  4. percent of incompletely apposed-uncovered struts [ Time Frame: 9 months ]
    to assess gender difference in % incompletely apposed/uncovered struts at 9 months follow up by OCT

  5. percent net volume obstruction [ Time Frame: 9 months ]
    To assess gender difference in % of stent volume obstruction by OCT at 9 months follow up

  6. percent abnormal intraluminal tissue [ Time Frame: 9 months ]
    To assess gender difference in % of abnormal intraluminal tissue by OCT at 9 months follow up

  7. percent of covered stent struts by OCT [ Time Frame: 9 months ]
    To assess gender differences in the percentage of covered stent struts by OCT at 9 months follow up.



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
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Acute Myocardial MI with ST segment Elevation, within 6 hours from symptoms onset
  • Native coronary artery disease (no prior stent implant, no prior brachytherapy)
  • Signed patient informed consent

Exclusion Criteria:

  • Patients with left main disease
  • infarct lesions in bypass grafts
  • cardiogenic shock
  • renal failure
  • recent major bleeding
  • allergy to aspirin or clopidogrel
  • on anticoagulant therapy
  • no suitable anatomy for OCT (extreme tortuousity, very distal culprit lesion, and large infarct vessel > 4 mm in diameter)

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): NCT02577965


Sponsors and Collaborators
A.O. Ospedale Papa Giovanni XXIII
Light Lab Imaging, Inc.
Investigators
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Principal Investigator: Giulio Guagliumi, MD Italian Society of Interventional Cardiology (GISE)

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Responsible Party: GGuagliumi, MD, A.O. Ospedale Papa Giovanni XXIII
ClinicalTrials.gov Identifier: NCT02577965    
Other Study ID Numbers: 5/01/2011-2
First Posted: October 16, 2015    Key Record Dates
Last Update Posted: October 16, 2015
Last Verified: October 2015
Keywords provided by GGuagliumi, A.O. Ospedale Papa Giovanni XXIII:
ST segment Elevation Myocardial Infarction
Optical Coherence Tomography
Percutaneous Coronary Intervention
Thrombus histopathology
Gender differences
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Sirolimus
Everolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents