Coronary Artery DiseaseNCT00192868
Drug Elution and Distal Protection During Percutaneous Coronary Intervention in ST Elevation Myocardial Infarction
A study testing Distal protection and drug eluting stent in people with Coronary Artery Disease, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The purpose of this study is to evaluate the clinical, echocardiographic and angiographic outcome of distal protection in the infarct related coronary artery and implantation of drug eluting versus bare metal stents in patients with ST-elevation myocardial infarctions treated acutely with percutaneous coronary… 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?
- Distal protection and drug eluting stent
- Type of treatment
- Surgery or procedure
- How many people
- 600 participants
- Where
- 1 siteDenmark
- Study dates
- May 2005to Nov 2011
- Phase
- Interventional
- 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
Who may be able to join
- Acute onset typical chest pain of < 12 hours' duration
- ST-elevation of > 4 mm (1mm = 0.1 mV) in contiguous leads of the electrocardiogram
- High grade stenosis or occlusion of a native major coronary artery that can be crossed with a soft or intermediate tip guidewire
- Possibility to perform distal protection of the infarct-related artery
Who cannot join
- History of previous myocardial infarction
- Use of fibrinolytic agents for the index infarction
- Left main stenosis
- Heavily calcification of abdominal aorta or occlusive iliofemoral disease hampering access to the coronary ostias by the femoral route
- Known renal failure
- Other significant cardiac disease
Show all 12Show fewer
- Other severe disease with an expected survival < 1 year
- Known allergy against clopidogrel or contrast media that can not be avoided/limited by medication
- Linguistic difficulties needing an interpreter
- Gastrointestinal bleeding within 1 month
- Childbearing potential or pregnancy
- Participation in another study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Drug Elution and DIstal Protection During Percutaneous CoronAry Intervention in sT Elevation Myocardial InfarctiON. Acronym: Dedication
The purpose of this study is to evaluate the clinical, echocardiographic and angiographic outcome of distal protection in the infarct related coronary artery and implantation of drug eluting versus bare metal stents in patients with ST-elevation myocardial infarctions treated acutely with percutaneous coronary intervention.
- Conditions
- Coronary Artery Disease
- Being tested
- Distal protection and drug eluting stent
- Keywords
- primary PCI, distal protection, drug eluting stent, restenosis
- 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.
Distal protection and drug eluting stentProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
ST segment resolution
Measured: 90 min
Late loss (difference between minimal lumen diameter in stented segment immediately after and at 8 month follow up).
Measured: immediately after and at 8 month follow up
Secondary outcomes (6)
Restenosis
Measured: 8 months
maximal elevations in blood concentrations of CK-MB enzyme and troponin-T
Measured: Post procedure
wall motion index
Measured: During hospitalisation: day 3-5
Minimal lumen diameter
Measured: 8 months
frequency of binary restenosis (>50% diameter stenosis), diameter stenosis (%) in the stented segment.
Measured: 8 months
Occurrence of stent thrombosis and MACE.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startMay 2005
- Primary completionNov 2009 (estimated)
- Study completionNov 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Investigators
- Henning Kelbaek, MD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00192868
- Sponsor's protocol ID
- DEDICATION
- Status last verified
- Sep 2009
- First submitted
- 12 Sep 2005
- Last updated
- 23 Sep 2009
- Results posted
- No
Publications
Kaltoft A, Kelbaek H, Thuesen L, Lassen JF, Clemmensen P, Klovgaard L, Engstrom T, Botker HE, Saunamaki K, Krusell LR, Jorgensen E, Tilsted HH, Christiansen EH, Ravkilde J, Kober L, Kofoed KF, Terkelsen CJ, Helqvist S. Long-term outcome after drug-eluting versus bare-metal stent implantation in patients with ST-segment elevation myocardial infarction: 3-year follow-up of the randomized DEDICATION (Drug Elution and Distal Protection in Acute Myocardial Infarction) Trial. J Am Coll Cardiol. 2010 Aug 17;56(8):641-5. doi: 10.1016/j.jacc.2010.05.009.
PubMed 20688033Kaltoft A, Kelbaek H, Klovgaard L, Terkelsen CJ, Clemmensen P, Helqvist S, Lassen JF, Thuesen L. Increased rate of stent thrombosis and target lesion revascularization after filter protection in primary percutaneous coronary intervention for ST-segment elevation myocardial infarction: 15-month follow-up of the DEDICATION (Drug Elution and Distal Protection in ST Elevation Myocardial Infarction) trial. J Am Coll Cardiol. 2010 Mar 2;55(9):867-71. doi: 10.1016/j.jacc.2009.09.052.
PubMed 20185036Kelbaek H, Thuesen L, Helqvist S, Clemmensen P, Klovgaard L, Kaltoft A, Andersen B, Thuesen H, Engstrom T, Botker HE, Saunamaki K, Krusell LR, Jorgensen E, Hansen HH, Christiansen EH, Ravkilde J, Kober L, Kofoed KF, Terkelsen CJ, Lassen JF; DEDICATION Investigators. Drug-eluting versus bare metal stents in patients with st-segment-elevation myocardial infarction: eight-month follow-up in the Drug Elution and Distal Protection in Acute Myocardial Infarction (DEDICATION) trial. Circulation. 2008 Sep 9;118(11):1155-62. doi: 10.1161/CIRCULATIONAHA.107.758698. Epub 2008 Aug 25.
PubMed 18725489Kelbaek H, Terkelsen CJ, Helqvist S, Lassen JF, Clemmensen P, Klovgaard L, Kaltoft A, Engstrom T, Botker HE, Saunamaki K, Krusell LR, Jorgensen E, Hansen HH, Christiansen EH, Ravkilde J, Kober L, Kofoed KF, Thuesen L. Randomized comparison of distal protection versus conventional treatment in primary percutaneous coronary intervention: the drug elution and distal protection in ST-elevation myocardial infarction (DEDICATION) trial. J Am Coll Cardiol. 2008 Mar 4;51(9):899-905. doi: 10.1016/j.jacc.2007.10.047.
PubMed 18308157
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Elution and DIstal Protection During Percutaneous CoronAry Intervention in sT Elevation Myocardial InfarctiON. Acronym: Dedication
- ClinicalTrials.gov ID
- NCT00192868
- Acronym / sponsor ID
- DEDICATION
- Conditions
- Coronary Artery Disease
- Keywords
- primary PCI, distal protection, drug eluting stent, restenosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- May 2005
- Primary completion
- Nov 2009 (estimated)
- Study completion
- Nov 2011 (estimated)
- First posted
- 19 Sep 2005 (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 evaluate the clinical, echocardiographic and angiographic outcome of distal protection in the infarct related coronary artery and implantation of drug eluting versus bare metal stents in patients with ST-elevation myocardial infarctions treated acutely with percutaneous coronary intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Acute onset typical chest pain of < 12 hours' duration
- ST-elevation of > 4 mm (1mm = 0.1 mV) in contiguous leads of the electrocardiogram
- High grade stenosis or occlusion of a native major coronary artery that can be crossed with a soft or intermediate tip guidewire
- Possibility to perform distal protection of the infarct-related artery
Key exclusion criteria (12 listed)
- History of previous myocardial infarction
- Use of fibrinolytic agents for the index infarction
- Left main stenosis
- Heavily calcification of abdominal aorta or occlusive iliofemoral disease hampering access to the coronary ostias by the femoral route
- Known renal failure
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 |
|---|---|---|
| Distal protection and drug eluting stent | Procedure or surgery | – |
Primary outcome
ST segment resolution
Time frame: 90 min
Late loss (difference between minimal lumen diameter in stented segment immediately after and at 8 month follow up).
Time frame: immediately after and at 8 month follow up
6 secondary outcomes
Restenosis
Time frame: 8 months
maximal elevations in blood concentrations of CK-MB enzyme and troponin-T
Time frame: Post procedure
wall motion index
Time frame: During hospitalisation: day 3-5
Minimal lumen diameter
Time frame: 8 months
frequency of binary restenosis (>50% diameter stenosis), diameter stenosis (%) in the stented segment.
Time frame: 8 months
Occurrence of stent thrombosis and MACE.
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2009.
- Derived from this study: PubMed 20688033Kaltoft A, Kelbaek H, Thuesen L, Lassen JF, Clemmensen P, Klovgaard L, Engstrom T, Botker HE, Saunamaki K, Krusell LR, Jorgensen E, Tilsted HH, Christiansen EH, Ravkilde J, Kober L, Kofoed KF, Terkelsen CJ, Helqvist S. Long-term outcome after drug-eluting versus bare-metal stent implantation in patients with ST-segment elevation myocardial infarction: 3-year follow-up of the randomized DEDICATION (Drug Elution and Distal Protection in Acute Myocardial Infarction) Trial. J Am Coll Cardiol. 2010 Aug 17;56(8):641-5. doi: 10.1016/j.jacc.2010.05.009.
- Derived from this study: PubMed 20185036Kaltoft A, Kelbaek H, Klovgaard L, Terkelsen CJ, Clemmensen P, Helqvist S, Lassen JF, Thuesen L. Increased rate of stent thrombosis and target lesion revascularization after filter protection in primary percutaneous coronary intervention for ST-segment elevation myocardial infarction: 15-month follow-up of the DEDICATION (Drug Elution and Distal Protection in ST Elevation Myocardial Infarction) trial. J Am Coll Cardiol. 2010 Mar 2;55(9):867-71. doi: 10.1016/j.jacc.2009.09.052.
- Derived from this study: PubMed 18725489Kelbaek H, Thuesen L, Helqvist S, Clemmensen P, Klovgaard L, Kaltoft A, Andersen B, Thuesen H, Engstrom T, Botker HE, Saunamaki K, Krusell LR, Jorgensen E, Hansen HH, Christiansen EH, Ravkilde J, Kober L, Kofoed KF, Terkelsen CJ, Lassen JF; DEDICATION Investigators. Drug-eluting versus bare metal stents in patients with st-segment-elevation myocardial infarction: eight-month follow-up in the Drug Elution and Distal Protection in Acute Myocardial Infarction (DEDICATION) trial. Circulation. 2008 Sep 9;118(11):1155-62. doi: 10.1161/CIRCULATIONAHA.107.758698. Epub 2008 Aug 25.
- Derived from this study: PubMed 18308157Kelbaek H, Terkelsen CJ, Helqvist S, Lassen JF, Clemmensen P, Klovgaard L, Kaltoft A, Engstrom T, Botker HE, Saunamaki K, Krusell LR, Jorgensen E, Hansen HH, Christiansen EH, Ravkilde J, Kober L, Kofoed KF, Thuesen L. Randomized comparison of distal protection versus conventional treatment in primary percutaneous coronary intervention: the drug elution and distal protection in ST-elevation myocardial infarction (DEDICATION) trial. J Am Coll Cardiol. 2008 Mar 4;51(9):899-905. doi: 10.1016/j.jacc.2007.10.047.
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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.
Henning Kelbaek, MD principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Distal protection and drug eluting stent in people with Coronary Artery Disease, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 4 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 23 Sep 2009. 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 Denmark. 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?
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?
ST segment resolution (time frame: 90 min). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00192868, which also lists 4 linked publications.
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 23 Sep 2009.