Ischemic Heart DiseaseNCT00487812
Low-Dose Dobutamine Tc-99m-Mibi Gated SPECT to Predict Left Ventricular Remodelling in Patients Reperfused in the Acute Phase of MI
A study testing Low-dose dobutamine Tc-99-m-mibi gated SPECT imaging in people with Ischemic Heart Disease and Myocardial Infarction, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Left myocardial infarction (MI), has a negative impact of long term morbidity and mortality. Even in patients treated successfully by angioplasty in the acute phase of infarct, the remodelling is observed in approximately 30% of cases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Heart Disease, Myocardial Infarction
- What is being tested?
- Low-dose dobutamine Tc-99-m-mibi gated SPECT imaging
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2004to Sep 2008
- 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 myocardial infarction,
- Successful coronary angioplasty in the acute phase,
- Absence of heart failure in the acute phase
Who cannot join
- acute heart failure in the acute phase
- severe ventricular arrhythmias
- contra indications for MRI imaging
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prediction of Left Ventricular Remodelling in Patients Treated by Angioplasty in the Acute of Phase of a First Myocardial Infarction by Low-Dose Dobutamine Tc-99m-Mibi Gated SPECT
Left myocardial infarction (MI), has a negative impact of long term morbidity and mortality. Even in patients treated successfully by angioplasty in the acute phase of infarct, the remodelling is observed in approximately 30% of cases. It is important to predict the occurrence of this phenomenon in the early phase after MI for the selection of patients who could eventually benefit from new therapeutic approach as for example cell replacement therapy. It has been advocated that stem cells coronary injections should be performed between the 5th and 10th day after an acute event. We hypothesise that a low dose dobutamine gated Tc-99m-mibi SPECT performed on 5th-6th day after reperfused acute MI can predict left ventricular remodelling and serve as a method to screen patients who could benefit from cell replacement therapy.
Read the detailed description
All patients will be evaluated by ce-MRI during the initial hospital stay (5th - 6th day) and at 6-month follow-up. Left ventricular remodelling will be defined as an end-diastolic volume increase of >20% between the two exams. A low dose dobutamine gated Tc-99m-mibi SPECT will be also performed on 5th-6th day. Differences in the infarct size and severity as well as the residual inotrope reserve in the infarct area are expected between groups with and without remodelling.
- Conditions
- Ischemic Heart Disease, Myocardial Infarction
- Being tested
- Low-dose dobutamine Tc-99-m-mibi gated SPECT imaging
- Keywords
- Acute myocardial infarction, left ventricular remodelling, SPECT imaging
- Medical subject headings
- Myocardial Ischemia, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose dobutamine Tc-99-m-mibi gated SPECT imagingProcedure or surgery
All patients will be evaluated by ce-MRI during the initial hospital stay (5th - 6th day)
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of left ventricular remodelling at 6-month follow-up
Measured: at 6-months follow-up
Secondary outcomes (1)
Development of overt heart failure
Measured: development of overt heart failure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2007 (estimated)
- Study startDec 2004
- Primary completionAug 2006
- Study completionSep 2008
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 Ischemic Heart 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Investigators
- Lipiecki Janusz, Dr, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00487812
- Sponsor's protocol ID
- CHU63-0017
- Status last verified
- Oct 2008
- First submitted
- 18 Jun 2007
- Last updated
- 7 Oct 2008
- Results posted
- No
Publications
Ernande L, Cachin F, Chabrot P, Durel N, Morand D, Boyer L, Maublant J, Lipiecki J. Rest and low-dose dobutamine Tc-99m-mibi gated-SPECT for early prediction of left ventricular remodeling after a first reperfused myocardial infarction. J Nucl Cardiol. 2009 Jul-Aug;16(4):597-604. doi: 10.1007/s12350-009-9098-5. Epub 2009 May 29.
PubMed 19479315
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Left Ventricular Remodelling in Patients Treated by Angioplasty in the Acute of Phase of a First Myocardial Infarction by Low-Dose Dobutamine Tc-99m-Mibi Gated SPECT
- ClinicalTrials.gov ID
- NCT00487812
- Acronym / sponsor ID
- CHU63-0017
- Conditions
- Ischemic Heart Disease, Myocardial Infarction
- Keywords
- Acute myocardial infarction, left ventricular remodelling, SPECT imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Dec 2004
- Primary completion
- Aug 2006 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 19 Jun 2007 (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.
Left myocardial infarction (MI), has a negative impact of long term morbidity and mortality. Even in patients treated successfully by angioplasty in the acute phase of infarct, the remodelling is observed in approximately 30% of cases. It is important to predict the occurrence of this phenomenon in the early phase after MI for the selection of patients who could eventually benefit from new therapeutic approach as for example cell replacement therapy. It has been advocated that stem cells coronary injections should be performed between the 5th and 10th day after an acute event. We hypothesise that a low dose dobutamine gated Tc-99m-mibi SPECT performed on 5th-6th day after reperfused acute MI can predict left ventricular remodelling and serve as a method to screen patients who could benefit from cell replacement therapy.
Detailed description
All patients will be evaluated by ce-MRI during the initial hospital stay (5th - 6th day) and at 6-month follow-up. Left ventricular remodelling will be defined as an end-diastolic volume increase of >20% between the two exams. A low dose dobutamine gated Tc-99m-mibi SPECT will be also performed on 5th-6th day. Differences in the infarct size and severity as well as the residual inotrope reserve in the infarct area are expected between groups with and without remodelling.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- 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 (3 listed)
- Acute myocardial infarction,
- Successful coronary angioplasty in the acute phase,
- Absence of heart failure in the acute phase
Key exclusion criteria (3 listed)
- acute heart failure in the acute phase
- severe ventricular arrhythmias
- contra indications for MRI imaging
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 |
|---|---|---|
| Low-dose dobutamine Tc-99-m-mibi gated SPECT imagingAll patients will be evaluated by ce-MRI during the initial hospital stay (5th - 6th day) | Procedure or surgery | – |
Primary outcome
Development of left ventricular remodelling at 6-month follow-up
Time frame: at 6-months follow-up
1 secondary outcome
Development of overt heart failure
Time frame: development of overt heart failure
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 7 Oct 2008.
- Derived from this study: PubMed 19479315Ernande L, Cachin F, Chabrot P, Durel N, Morand D, Boyer L, Maublant J, Lipiecki J. Rest and low-dose dobutamine Tc-99m-mibi gated-SPECT for early prediction of left ventricular remodeling after a first reperfused myocardial infarction. J Nucl Cardiol. 2009 Jul-Aug;16(4):597-604. doi: 10.1007/s12350-009-9098-5. Epub 2009 May 29.
Related trials for Ischemic Heart Disease
Not yet recruitingPhase 1/2
EDIT-401 in Adults Who Require Additional Lowering of Low-Density Lipoprotein Cholesterol (LDL-C)
Heterozygous Familial Hypercholesterolemia (HeFH)
Active, not recruitingPhase 3
Coronary Computed Tomography Study to Assess the Effect of Inclisiran in Addition to Maximally Tolerated Statin Therapy on Atherosclerotic Plaque Progression in Participants With a Diagnosis of Non-obstructive Coronary Artery Disease Without Previous Cardiovascular Events
Coronary Artery Disease
Active, not recruiting
Troponin in Acute Chest Pain to Risk Stratify and Guide EffecTive Use of Computed Tomography Coronary Angiography
Coronary Artery Disease
Recruiting
Impact of Atrial Fibrosis Surface Area on the Occurrence of Atrial Fibrillation in Patients With Ischemic Stroke of Undetermined Origin: a Prospective Cardiac MRI Pilot Study.
Stroke, Implantation of an Implantable Cardiac Monitor
Recruiting
A Prospective, Multicenter, Randomized Controlled Trial to Investigate the Value of Coronary CT Angiography in the Understanding and Management of Coronary Calcium (The Optimal Trial)
Cardiovascular Diseases, Myocardial Ischemia
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.
Lipiecki Janusz, Dr principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-dose dobutamine Tc-99-m-mibi gated SPECT imaging in people with Ischemic Heart Disease and Myocardial Infarction, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 3 inclusion and 3 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 7 Oct 2008. 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 France. 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?
Development of left ventricular remodelling at 6-month follow-up (time frame: at 6-months follow-up). 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 NCT00487812, 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 7 Oct 2008.