NCT01377207

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, high resolution Optical Coherence Tomography of the culprit vessel and histopathologic analyses of thrombus aspirates of the infarct related lesion, performed by independent core laboratories, blinded to group (male or female) and clinical variables.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2011

Typical duration for phase_4

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

January 25, 2011

Completed
5 months until next milestone

First Posted

Study publicly available on registry

June 21, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

April 19, 2013

Status Verified

April 1, 2013

Enrollment Period

2 years

First QC Date

January 25, 2011

Last Update Submit

April 18, 2013

Conditions

Acute Myocardial Infarction

Keywords

ST segment Elevation Myocardial InfarctionOptical Coherence TomographyPercutaneous Coronary InterventionThrombus hystopathologyGender differences

Outcome Measures

Primary Outcomes (2)

  • 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. The OCT measurement is taken before stenting, when a TIMI flow 2-3 is detected. If baseline flow is TIMI 1, thrombus aspiration is performed before OCT.

    Plaque rupture is evaluated during the index PCI procedure.

  • Percent of covered stent struts by OCT in infarct-related lesion at 9 months (co-primary endpoint).

    To assess gender differences in the percentage of covered stent struts at infarct related lesion as assessed by OCT performed in all patients at 9 months.

    Stent coverage is evaluated at 9 months by OCT performed in all patients.

Secondary Outcomes (6)

  • Minimal Fibrous Cap Thickness (MFCA) (µm) at infarct-related lesion as determined by OCT.

    MFCA at index procedure (immediately after reestablishment of TIMI 2-3 coronary flow by PCI) and at 9 months OCT performed in all patients.

  • Presence and type of residual thrombus material in the culprit vessel.

    Residual thrombus in the infarct related vessel is evaluated during the index procedure: immediately after reestablishment of TIMI 2-3 coronary flow during primary percutaneous coronary intervention

  • Number of TCFA (<65 µM) as assessed by OCT in the culprit vessel (infarct related).

    Thin Fibrous Cap Atheroma is assessed during the index procedure: immediately after reestablishment of TIMI 2-3 coronary flow before stent implantationduring PCI; and at 9 months by OCT performed in all patients.

  • percent of malapposed-uncovered struts

    9 months

  • percent net volume obstruction

    9 months

  • +1 more secondary outcomes

Study Arms (2)

Female Arm

EXPERIMENTAL

Female gender diagnosed with ST segment Elevation Myocardial Infarction (STEMI)

Procedure: Primary PCI

Male Arm

ACTIVE COMPARATOR

Male Gender diagnosed with ST segment Elevation Acute Myocardial Infarction (STEMI)

Procedure: Primary PCI

Interventions

Primary PCIPROCEDURE

Thrombus aspiration and hystopathological analysis, Optical Coherence Tomography assessment of STEMI culprit vessel, Primary PCI with Drug Eluting Stent implantation; Repeat OCT assessment of culprit vessel at 9 monts follow-up

Female ArmMale Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Ospedale Cardinal Massai

Asti, AT, 14100, Italy

Location

Ospedali Riuniti di Bergamo

Bergamo, BG, 24124, Italy

Location

Policlinico S.Orsola- Malpighi

Bologna, BO, Italy

Location

Ospedale Ferrarotto

Catania, CT, Italy

Location

Ospedale S. Anna

Ferrara, FE, 44100, Italy

Location

USL 9 Grosseto

Grosseto, GR, 48100, Italy

Location

Policlinico Gemelli

Rome, Italy, 00168, Italy

Location

Policlinico Padova

Padua, PD, Italy

Location

Policlinico Parma

Parma, PR, 43126, Italy

Location

Policlinico Le Scotte

Siena, SI, 53100, Italy

Location

Ospedale San Giovanni Bosco

Torino, TO, 10154, Italy

Location

Ospedale Le Molinette

Torino, TO, Italy

Location

Ospedale Mauriziano

Torino, TO, Italy

Location

Ospedale Civile

Mirano, VE, Italy

Location

Related Publications (2)

  • Saia F, Komukai K, Capodanno D, Sirbu V, Musumeci G, Boccuzzi G, Tarantini G, Fineschi M, Tumminello G, Bernelli C, Niccoli G, Coccato M, Bordoni B, Bezerra H, Biondi-Zoccai G, Virmani R, Guagliumi G; OCTAVIA Investigators. Eroded Versus Ruptured Plaques at the Culprit Site of STEMI: In Vivo Pathophysiological Features and Response to Primary PCI. JACC Cardiovasc Imaging. 2015 May;8(5):566-575. doi: 10.1016/j.jcmg.2015.01.018. Epub 2015 Apr 15.

    PMID: 25890582DERIVED

  • Guagliumi G, Capodanno D, Saia F, Musumeci G, Tarantini G, Garbo R, Tumminello G, Sirbu V, Coccato M, Fineschi M, Trani C, De Benedictis M, Limbruno U, De Luca L, Niccoli G, Bezerra H, Ladich E, Costa M, Biondi Zoccai G, Virmani R; OCTAVIA Trial Investigators. Mechanisms of atherothrombosis and vascular response to primary percutaneous coronary intervention in women versus men with acute myocardial infarction: results of the OCTAVIA study. JACC Cardiovasc Interv. 2014 Sep;7(9):958-68. doi: 10.1016/j.jcin.2014.05.011. Epub 2014 Aug 13.

    PMID: 25129664DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Giulio Guagliumi, MD

    Italian Society of Invasive Cardiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2011

First Posted

June 21, 2011

Study Start

January 1, 2011

Primary Completion

January 1, 2013

Study Completion

April 1, 2013

Last Updated

April 19, 2013

Record last verified: 2013-04

Locations

IT(14)