Myocardial InfarctionGHOSTNCT01018706
Goodness of Clinical History During Stemi PCI
An observational study of Myocardial Infarction, run by Umberto I Hospital, Frosinone Italy at 1 site in Italy.
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 … Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction
- How many people
- 400 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2010to Mar 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Four hundred patients with STEMI treated with primary PCI or rescue PCI.
Who may be able to join
- All consecutive patients presenting with STEMI treated with primary or rescue PCI
Who cannot join
- Patient in cardiogenic shock and all those patients unable to communicate with the doctors at the moment of medical history taking
Trial locations and contacts
1 site in 1 country.
Italy1 site
Interventional cardiology divisione , Umberto I Hospital
Frosinone, Frosinone
About this study
Official title: Goodness of Clinical History During Stemi PCI (GHOST)
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.
Read the 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.
- Conditions
- Myocardial Infarction
- Keywords
- Primary pci, Stent, Medical Hystory, Antiplatelet therapy, Compliance
- Medical subject headings
- Myocardial Infarction, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| STEMI patients treated with PCI | Four hundred patients with STEMI treated with primary PCI or rescue PCI. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adequacy of medical history collection at the moment of primary pci and 4 days after the index procedure
Measured: Adequacy of medical history collection at the moment of primary pci and 4 days after the index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2009 (estimated)
- Study startMar 2010
- Primary completionJan 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umberto I Hospital, Frosinone Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Menichelli Maurizio, Umberto I Hospital, Frosinone Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01018706
- Sponsor's protocol ID
- GHOST
- Acronym
- GHOST
- Status last verified
- Dec 2013
- First submitted
- 24 Nov 2009
- Last updated
- 17 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Goodness of Clinical History During Stemi PCI (GHOST)
- ClinicalTrials.gov ID
- NCT01018706
- Acronym / sponsor ID
- GHOST / GHOST
- Conditions
- Myocardial Infarction
- Keywords
- Primary pci, Stent, Medical Hystory, Antiplatelet therapy, Compliance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Umberto I Hospital, Frosinone ItalyUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 25 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STEMI patients treated with PCI | – | –Four hundred patients with STEMI treated with primary PCI or rescue PCI. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Four hundred patients with STEMI treated with primary PCI or rescue PCI.
Key inclusion criteria (1 listed)
- All consecutive patients presenting with STEMI treated with primary or rescue PCI
Key exclusion criteria (1 listed)
- Patient in cardiogenic shock and all those patients unable to communicate with the doctors at the moment of medical history taking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction, run by Umberto I Hospital, Frosinone Italy at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2013.