Coronary Artery DiseaseADVANCE-PCINCT00905294
Study of ADAMTS-13 Activity, Von Willebrand Factor and Platelet-Monocyte Aggregation in Coronary Artery Disease
An observational study of Coronary Artery Disease, run by University College Cork at 2 sites in Ireland.
Trial summary
The purpose of this research is to determine the relationship between proteins and enzymes in the blood and how they work with platelets to form blood clots in patients with coronary artery disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Blood draws
- How many people
- 11 participants
- Where
- 2 sitesIreland
- Study dates
- Aug 2009to Aug 2010
- 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: Patients with coronary artery disease undergoing percutaneous coronary intervention
Who may be able to join
- Admission to hospital with suspected index event of Non-ST-Elevation Myocardial Infarction (NSTEMI), Unstable Angina (UA) or Stable Angina (SA)
- Planned percutaneous coronary intervention during admission
Who cannot join
- Recent history (< 6 months) of an acute coronary syndrome (other than current admission) or stroke
- Recent history (< 6 months) of major surgery, trauma or thromboembolic event
- Percutaneous coronary or peripheral intervention or any stent placement performed within the past 6 months
- Current evidence of infection
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: ADAMTS-13 Activity, Von Willebrand Factor and Platelet-Monocyte Aggregation in Patients Undergoing Percutaneous Coronary Intervention
The purpose of this research is to determine the relationship between proteins and enzymes in the blood and how they work with platelets to form blood clots in patients with coronary artery disease. The investigators hypothesize that the relationship between these factors could potentially be useful in identifying patients at higher risk for heart attacks.
- Conditions
- Coronary Artery Disease
- Being tested
- Blood draws
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood drawsOther
Observational: blood draws only
| Study group | Role | What they receive |
|---|---|---|
| coronary artery disease | Subjects with coronary artery disease undergoing percutaneous coronary intervention Receives: Other: Blood draws |
What is being measured
The primary outcome is the main question the study is designed to answer.
relationships between ADAMTS-13 activity, von Willebrand factor antigen and platelet-monocyte aggregates levels
Assess the relationships between ADAMTS-13 activity, von Willebrand factor antigen and platelet-monocyte aggregates levels in subjects with coronary artery disease prior to and after undergoing PCI in this exploratory study
Measured: change from baseline to after percutaneous coronary intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2009 (estimated)
- Study startAug 2009
- Primary completionAug 2010
- Study completionAug 2010
Why it stopped: Funding withdrawn
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Cork
- Sponsor type
- University, hospital or other
- Collaborators
- Royal College of Surgeons, Ireland
- Responsible party
- Principal investigator, Professor Noel Caplice, University College Cork
- Investigators
- Noel M. Caplice, M.D, Ph.D., Principal investigator, University College Cork, IrelandDermot Kenny, M.D., Study director, Royal College Surgeons in IrelandDavid Foley, M.B., Study director, Beaumont Hospital, Dublin, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00905294
- Sponsor's protocol ID
- INFACTs 2009-001
- Acronym
- ADVANCE-PCI
- Status last verified
- Jun 2013
- First submitted
- 19 May 2009
- Last updated
- 19 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ADAMTS-13 Activity, Von Willebrand Factor and Platelet-Monocyte Aggregation in Patients Undergoing Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT00905294
- Acronym / sponsor ID
- ADVANCE-PCI / INFACTs 2009-001
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Funding withdrawn
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University College CorkUniversity, hospital or other
- Collaborators
- Royal College of Surgeons, Ireland
- Study start
- Aug 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 20 May 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 research is to determine the relationship between proteins and enzymes in the blood and how they work with platelets to form blood clots in patients with coronary artery disease. The investigators hypothesize that the relationship between these factors could potentially be useful in identifying patients at higher risk for heart attacks.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| coronary artery disease | – | Other: Blood drawsSubjects with coronary artery disease undergoing percutaneous coronary intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with coronary artery disease undergoing percutaneous coronary intervention
Key inclusion criteria (2 listed)
- Admission to hospital with suspected index event of Non-ST-Elevation Myocardial Infarction (NSTEMI), Unstable Angina (UA) or Stable Angina (SA)
- Planned percutaneous coronary intervention during admission
Key exclusion criteria (4 listed)
- Recent history (< 6 months) of an acute coronary syndrome (other than current admission) or stroke
- Recent history (< 6 months) of major surgery, trauma or thromboembolic event
- Percutaneous coronary or peripheral intervention or any stent placement performed within the past 6 months
- Current evidence of infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood drawsObservational: blood draws only | Other | coronary artery disease |
Primary outcome
relationships between ADAMTS-13 activity, von Willebrand factor antigen and platelet-monocyte aggregates levels
Time frame: change from baseline to after percutaneous coronary intervention
Assess the relationships between ADAMTS-13 activity, von Willebrand factor antigen and platelet-monocyte aggregates levels in subjects with coronary artery disease prior to and after undergoing PCI in this exploratory study
Results and safety
The study was stopped early (reason given: Funding withdrawn). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 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.
Noel M. Caplice, M.D, Ph.D. principal investigator
University College Cork, Ireland
Dermot Kenny, M.D. study director
Royal College Surgeons in Ireland
David Foley, M.B. study director
Beaumont Hospital, Dublin, Ireland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by University College Cork at 2 sites in Ireland.
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 2 inclusion and 4 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: stopped early, as of the sponsor's last update on 19 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ireland. 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 was stopped early (reason given: Funding withdrawn). Results are not available in the source record.
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?
relationships between ADAMTS-13 activity, von Willebrand factor antigen and platelet-monocyte aggregates levels (time frame: change from baseline to after percutaneous coronary intervention). 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 19 Jun 2013.