Acute Myocardial InfarctionPhase 2NCT00409604
PROTECT : Pacing to Protect Heart for Damage From Blocked Heart Vessel and From Re-opening Blocked Vessel(s)
A Phase 2 study testing Temporary RV VVI pacing in people with Acute Myocardial Infarction, run by Guidant Corporation at 1 site in Netherlands.
Trial summary
To determine whether the application of ventricular pacing can protect the human heart from damage resulting from a myocardial infarction Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- Temporary RV VVI pacing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteNetherlands
- Study dates
- Dec 2006to Aug 2009
- Phase
- Phase 2
- 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
- Clinical diagnosis of acute myocardial infarction, requiring PCI within 2 to 6 hours following symptoms
- Total occlusion of a coronary artery with reference vessel diameter >or= 3mm
Who cannot join
- Thrombolitics
- Severe bradycardia requiring cardiac pacing
- Previous PCI or CABG
- Recent stroke or CV surgery
- Recent major surgery or trauma
- Clinical and hemodynamic unstability
Show all 13Show fewer
- Implanted CRM device
- Evidence of previous MI
- Diabetes using rosiglitazone or other fibrates
- Permanent AF
- Mechanical tricuspid valve
- Pregnancy
- Incapability of participating in exercise test
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of Pacing During the Onset of Revascularization / Feasibility Study
To determine whether the application of ventricular pacing can protect the human heart from damage resulting from a myocardial infarction
Read the detailed description
To determine whether the application of ventricular pacing can protect the human heart from damage resulting from a myocardial infarction
- Conditions
- Acute Myocardial Infarction
- Being tested
- Temporary RV VVI pacing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temporary RV VVI pacingDevice
temporary pacing at the onset of revascularisation
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Standard PCI procedure + pacing post conditioning Receives: Device: Temporary RV VVI pacing |
| 2 | No intervention | Standard PCI procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infarct size (area under the curve of creatine kinase) at baseline compared with MRI at 4 months and at 12 months
Measured: 4 & 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2006 (estimated)
- Study startDec 2006
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guidant Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- JOhannes Waltenberger, Prof.Dr., Principal investigator, University Hospital of Maastricht (azM), P. Debyelaan 25, 6202 AZ Maastricht, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00409604
- Sponsor's protocol ID
- CS1017-001
- Status last verified
- Aug 2010
- First submitted
- 8 Dec 2006
- Last updated
- 31 Aug 2010
- Results posted
- No
Publications
Waltenberger J, Gelissen M, Bekkers SC, Vainer J, van Ommen V, Eerens F, Ruiters A, Holthuijsen A, Cuesta P, Strauven R, Mokelke E, Gorgels A, Prinzen FW. Clinical pacing post-conditioning during revascularization after AMI. JACC Cardiovasc Imaging. 2014 Jun;7(6):620-6. doi: 10.1016/j.jcmg.2014.01.017.
PubMed 24925330
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Pacing During the Onset of Revascularization / Feasibility Study
- ClinicalTrials.gov ID
- NCT00409604
- Acronym / sponsor ID
- CS1017-001
- Conditions
- Acute Myocardial Infarction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Guidant CorporationIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 11 Dec 2006 (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.
To determine whether the application of ventricular pacing can protect the human heart from damage resulting from a myocardial infarction
Detailed description
To determine whether the application of ventricular pacing can protect the human heart from damage resulting from a myocardial infarction
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Temporary RV VVI pacingStandard PCI procedure + pacing post conditioning |
| 2 | No intervention | –Standard PCI procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of acute myocardial infarction, requiring PCI within 2 to 6 hours following symptoms
- Total occlusion of a coronary artery with reference vessel diameter >or= 3mm
Key exclusion criteria (13 listed)
- Thrombolitics
- Severe bradycardia requiring cardiac pacing
- Previous PCI or CABG
- Recent stroke or CV surgery
- Recent major surgery or trauma
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 |
|---|---|---|
| Temporary RV VVI pacingtemporary pacing at the onset of revascularisation | Device | 1 |
Primary outcome
Infarct size (area under the curve of creatine kinase) at baseline compared with MRI at 4 months and at 12 months
Time frame: 4 & 12 months
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 31 Aug 2010.
- Derived from this study: PubMed 24925330Waltenberger J, Gelissen M, Bekkers SC, Vainer J, van Ommen V, Eerens F, Ruiters A, Holthuijsen A, Cuesta P, Strauven R, Mokelke E, Gorgels A, Prinzen FW. Clinical pacing post-conditioning during revascularization after AMI. JACC Cardiovasc Imaging. 2014 Jun;7(6):620-6. doi: 10.1016/j.jcmg.2014.01.017.
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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.
JOhannes Waltenberger, Prof.Dr. principal investigator
University Hospital of Maastricht (azM), P. Debyelaan 25, 6202 AZ Maastricht, The Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Temporary RV VVI pacing in people with Acute Myocardial Infarction, run by Guidant Corporation at 1 site in Netherlands.
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 13 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 31 Aug 2010. 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 Netherlands. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Infarct size (area under the curve of creatine kinase) at baseline compared with MRI at 4 months and at 12 months (time frame: 4 & 12 months). 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 NCT00409604, which also lists 1 linked publication.
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 31 Aug 2010.