Goodness of Clinical History During Stemi PCI (GHOST)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Menichelli Maurizio, Umberto I Hospital, Frosinone Italy
ClinicalTrials.gov Identifier:
NCT01018706
First received: November 24, 2009
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

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.


Condition
Myocardial Infarction

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Goodness of Clinical History During Stemi PCI (GHOST)

Further study details as provided by Umberto I Hospital, Frosinone Italy:

Primary Outcome Measures:
  • Adequacy of medical history collection at the moment of primary pci and 4 days after the index procedure [ Time Frame: Adequacy of medical history collection at the moment of primary pci and 4 days after the index procedure ] [ Designated as safety issue: No ]

Enrollment: 400
Study Start Date: March 2010
Study Completion Date: March 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
STEMI patients treated with PCI
Four hundred patients with STEMI treated with primary PCI or rescue PCI.

Detailed Description:

GHOST Registry

Use of drug-eluting stent (DES) in STEMI is sometimes limited, by the concern that adequate information, relating to the current or previous medical history, can not be obtained due to the patient's critical condition. A less than adequate medical history would expose patients treated with DES to a particular risk in case that an absolute or relative contraindication to the required long-term double antiplatelet therapy is not fully elucidated before DES implantation.

To confirm or confute the hypothesis that in patients treated with primary pci is not always possible to collect an adequate medical history, we created a clinical registry in which we collect current or previous medical history relevant to DES utilization , in two distinct times:

Time zero in which the medical history collection is taken in the cath-lab during the primary pci

Time one in which the second medical history collection is taken 4 days after the index procedure when the patient clinical conditions no longer impede an adequate medical history collection.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patient in cardiogenic shock and all those patients unable to communicate with the doctors at the moment of medical history taking
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01018706

Locations
Italy
Interventional cardiology divisione , Umberto I Hospital
Frosinone, Italy
Sponsors and Collaborators
Umberto I Hospital, Frosinone Italy
  More Information

No publications provided

Responsible Party: Menichelli Maurizio, Director of Cardiology Division, Umberto I Hospital, Frosinone Italy
ClinicalTrials.gov Identifier: NCT01018706     History of Changes
Other Study ID Numbers: GHOST
Study First Received: November 24, 2009
Last Updated: December 16, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by Umberto I Hospital, Frosinone Italy:
Primary pci
Stent
Medical Hystory
Antiplatelet therapy
Compliance

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 29, 2014