Goodness of Clinical History During Stemi PCI

Myocardial Infarction Clinical Trial

— GHOST  

Official title:

Goodness of Clinical History During Stemi PCI (GHOST)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01018706
• Other study ID #: GHOST
• Status: Completed
• Phase: N/A
• First received: November 24, 2009
• Last updated: December 16, 2013
• Start date: March 2010
• Est. completion date: March 2012

Study information

• Verified date: December 2013
• Source: Umberto I Hospital, Frosinone Italy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: March 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Myocardial Infarction

Locations

Country	Name	City	State
Italy	Interventional cardiology divisione , Umberto I Hospital	Frosinone

Sponsors (1)

Lead Sponsor	Collaborator
Umberto I Hospital, Frosinone Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No