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

NCT02577965 | Completed Phase 4 DMC

• 1 other identifier: 5/01/2011-2
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Acute Myocardial Infarction

Keywords

ST segment Elevation Myocardial Infarction; Optical Coherence Tomography; Percutaneous Coronary Intervention; Thrombus histopathology; Gender differences

Outcome Measures

Primary Outcomes (1)

• percentage of ruptured or eroded plaques at infarct related lesion as assessed by OCT before PCI

  To assess gender differences in the percentage of ruptured or eroded plaques at infarct related lesion as assessed by OCT before PCI.

  within 6 hours from symptoms onset

Secondary Outcomes (7)

• Minimal Fibrous Cap Thickness (µm) at infarct-related lesion.

  within 6 hours from symptoms onset

• Presence and type of thrombus at culprit site

  within 6 hours from symptoms onset

• Number of Thin Cat Fibroatheroma (TCFA) (<65 µM) in the scanned segment.

  within 6 hours from symptoms onset

• percent of incompletely apposed-uncovered struts

  9 months

• percent net volume obstruction

  9 months

Study Arms (2)

Female Arm

EXPERIMENTAL

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; Device: XIENCE PRIME Everolimus Eluting Coronary Stent System

Male Arm

ACTIVE COMPARATOR

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; Device: XIENCE PRIME Everolimus Eluting Coronary Stent System

Interventions

Percutaneous Coronary Intervention PROCEDURE

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

Female Arm; Male Arm

XIENCE PRIME Everolimus Eluting Coronary Stent System DEVICE

Xience Prime Everolimus Eluting Coronary Stent System implantation to treat Acute Myocardial Infarction

Female Arm; Male Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• A.O. Ospedale Papa Giovanni XXIII: lead
• Light Lab Imaging, Inc.: collaborator

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Giulio Guagliumi, MD

  Italian Society of Interventional Cardiology (GISE)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 15, 2014
• First Posted: October 16, 2015
• Study Start: March 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: September 1, 2014
• Last Updated: October 16, 2015

Record last verified: 2015-10