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

NCT02577965 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2015-10-16

No results posted yet for this study

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).

Conditions

  • Acute Myocardial Infarction

Interventions

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

Sponsors & Collaborators

  • Light Lab Imaging, Inc.

    collaborator INDUSTRY

  • A.O. Ospedale Papa Giovanni XXIII

    lead OTHER

Principal Investigators

  • Giulio Guagliumi, MD · Italian Society of Interventional Cardiology (GISE)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2012-06-30
Completion
2014-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02577965 on ClinicalTrials.gov