NCT01462188

Brief Summary

The goal of primary PCI is to restore anterograde myocardial flow. Stenting a largely thrombotic lesion may determine distal embolisation of thrombotic material therefore deteriorating myocardial perfusion.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2011

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

October 1, 2011

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

October 24, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 31, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

October 31, 2011

Status Verified

October 1, 2011

Enrollment Period

1 year

First QC Date

October 24, 2011

Last Update Submit

October 28, 2011

Conditions

Myocardial Infarction

Keywords

ST-segment elevation myocardial infarctionPrimary angioplastystent

Outcome Measures

Primary Outcomes (1)

  • Myocardial blush grade (MBG) equal or greater than 2

    The MBG will be estimated visually by 2 experienced observers, as previously described.

    post-procedure

Secondary Outcomes (7)

  • ST segment elevation resolution

    30 minutes after the procedure

  • ST segment elevation Resolution

    90 minutes after the procedure

  • infarct size

    5 days

  • Infarct size

    6 months

  • microvascular obstruction

    5 days

  • +2 more secondary outcomes

Study Arms (2)

Immediate stenting

ACTIVE COMPARATOR

Patients being randomized to the immediate stenting arm will be managed according to the guidelines. Irrespective of TIMI flow at presentation, investigators will be requested to thrombus aspirate immediately after successful wiring of the culprit vessel followed by direct stenting. In cases where insertion of thrombus removal catheter and/or direct stenting is not successful, balloon angioplasty will be allowed.

Procedure: Immediate stenting

Delayed stenting

EXPERIMENTAL

Patients being randomized to the delayed/staged stenting arm will be managed with the aim to obtain stable TIMI 3 flow with no considerations given at the percentage of residual stenosis at the culprit lesion. In patients presenting with TIMI 3 flow, investigators will be left free to wire the vessel and proceed to thrombus aspiration to decrease thrombus burden in the culprit lesion or to leave the vessel untreated at the time of index PCI. Patients presenting with suboptimal TIMI flow (i.e. less than 3), investigators are required to wire the vessel and thrombus aspirate. If stable (persisting for at least 5 minutes) TIMI 3 flow is obtained, investigators are requested to stop the procedure. The goal is to achieve s table TIMI 3 flow with no considerations given to the percentage of residual stenosis. Stenting in this arm will be allowed only on a bail-out strategy.

Procedure: Delayed stenting

Interventions

Immediate stentingPROCEDURE

Primary coronary stenting

Immediate stenting
Delayed stentingPROCEDURE

Coronary stenting 3 to 7 days after having reopened the vessel in the acute phase

Delayed stenting

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • chest pain for \>30 min with ST-segment elevation of one mm or more in 2 or more contiguous ECG leads or with presumably new left bundle-branch block
  • admission either within 12 h of symptom onset or between 12 and 24 h with evidence of continuing ischaemia

You may not qualify if:

  • inability to assume an oral P2Y12 receptor blocker on a consecutive daily basis for a minimum of 6 months, or to heparin or aspirin
  • uncontrolled hypertension (systolic or diastolic arterial pressure \>180 mmHg or 120, respectively, despite medical therapy)
  • limited life expectancy, e.g. neoplasms, others
  • inability to obtain informed consent
  • pregnancy
  • patients were not enrolled if they were clinically unstable, presented with severe arrhythmia, or had known contraindications to CMR (claustrophobia, pacemakers, or implantable defibrillator devices)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

U.O. Cardiologia

Ferrara, Emilia-Romagna, 44100, Italy

RECRUITING

MeSH Terms

Conditions

Myocardial InfarctionST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Central Study Contacts

Alessandro Dal Monte, MD

CONTACT

3487243479dalmo_it@yahoo.it

Marco Valgimigli, MD, PhD

CONTACT

3356478877vlgmrc@unife.it

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 INVESTIGATOR
PI Title
Head of the Catheterization laboratory

Study Record Dates

First Submitted

October 24, 2011

First Posted

October 31, 2011

Study Start

October 1, 2011

Primary Completion

October 1, 2012

Study Completion

October 1, 2015

Last Updated

October 31, 2011

Record last verified: 2011-10

Locations

IT(1)