NCT01018706

Brief Summary

The purpose of this study is to confirm or confute the hypothesis that in patients treated with primary pci is not always possible to collect an adequate medical history, the investigators created a clinical registry in which the investigators collect current or previous medical history relevant to DES utilization , in two distinct times.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2010

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

November 24, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 25, 2009

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

December 17, 2013

Status Verified

December 1, 2013

Enrollment Period

1.8 years

First QC Date

November 24, 2009

Last Update Submit

December 16, 2013

Conditions

Myocardial Infarction

Keywords

Primary pciStentMedical HystoryAntiplatelet therapyCompliance

Outcome Measures

Primary Outcomes (1)

  • Adequacy of medical history collection at the moment of primary pci and 4 days after the index procedure

    Adequacy of medical history collection at the moment of primary pci and 4 days after the index procedure

Study Arms (1)

STEMI patients treated with PCI

Four hundred patients with STEMI treated with primary PCI or rescue PCI.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Four hundred patients with STEMI treated with primary PCI or rescue PCI.

You may qualify if:

  • All consecutive patients presenting with STEMI treated with primary or rescue PCI

You may not qualify if:

  • Patient in cardiogenic shock and all those patients unable to communicate with the doctors at the moment of medical history taking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Interventional cardiology divisione , Umberto I Hospital

Frosinone, Frosinone, Italy

Location

MeSH Terms

Conditions

Myocardial InfarctionPatient Compliance

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Cardiology Division

Study Record Dates

First Submitted

November 24, 2009

First Posted

November 25, 2009

Study Start

March 1, 2010

Primary Completion

January 1, 2012

Study Completion

March 1, 2012

Last Updated

December 17, 2013

Record last verified: 2013-12

Locations

IT(1)