Diabetes Mellitus, Type 2Phase 4NCT00162357
Post-PCI:Cardiac Imaging in Patients With Diabetes to Detect Coronary Artery Blockages Previously Opened by Angioplasty
A Phase 4 study testing Technetium Tc99m Sestamibi in people with Diabetes Mellitus, Type 2 and Coronary Restenosis, run by Lantheus Medical Imaging at 8 sites in 2 countries.
Trial summary
The purpose of this clinical research study is determine if patients with diabetes that have undergone previous opening of a heart blockage may have a blockage that is not causing any symptoms that may be detected by imaging with Cardiolite. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Coronary Restenosis
- What is being tested?
- Technetium Tc99m Sestamibi
- How many people
- 106 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Apr 2004to Dec 2005
- Phase
- Phase 4
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type II Diabetes on medication \& angioplasty within the past 6 months.
Who cannot join
- Myocardial infarction or repeat angioplasty with the past 5 months.
- Unable to perform exercise or pharmacologic stress test.
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United States7 sites
Local Institution
Burlington, Vermont
Local Institution
Grand Rapids, Michigan
Local Institution
Hartford, Connecticut
Local Institution
Roanoke, Virginia
Local Institution
Roslyn, New York
Local Institution
Waterbury, Connecticut
Local Institution
Wausau, Wisconsin
About this study
Official title: Cardiolite-406; A Phase IV Open-Label, Randomized, Multi-Center Trial To Evaluate The Ability of Cardiolite Stress MPI to Detect Asymptomatic Restenosis in Diabetic Patients Who Have Undergone Percutaneous Coronary Intervention
The purpose of this clinical research study is determine if patients with diabetes that have undergone previous opening of a heart blockage may have a blockage that is not causing any symptoms that may be detected by imaging with Cardiolite.
- Conditions
- Diabetes Mellitus, Type 2, Coronary Restenosis
- Being tested
- Technetium Tc99m Sestamibi
- Medical subject headings
- Diabetes Mellitus, Type 2, Coronary Restenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technetium Tc99m SestamibiDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate symptom-free heart blockages that develop following initial opening in patients with Type II diabetes mellitus based on Cardiolite imaging
Secondary outcomes (3)
Determine how often symptom-free heart blockages occur 5-6 months after opening in patients with Type II diabetes mellitus
Examine the relative value of ejection fraction, summed stress, rest, and difference MPI scores for identifying patients with cardiac events during 18 month follow-up.
Compare patient hospital and out-patient cost for cardiac care for each group of patients (MPI versus standard care).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2005 (estimated)
- Study startApr 2004
- Primary completionDec 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lantheus Medical Imaging
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Qi Zhu, MD, Study director, Lantheus Medical Imaging
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00162357
- Sponsor's protocol ID
- CARDIOLITE-406
- Status last verified
- Apr 2011
- First submitted
- 9 Sep 2005
- Last updated
- 15 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiolite-406; A Phase IV Open-Label, Randomized, Multi-Center Trial To Evaluate The Ability of Cardiolite Stress MPI to Detect Asymptomatic Restenosis in Diabetic Patients Who Have Undergone Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT00162357
- Acronym / sponsor ID
- CARDIOLITE-406
- Conditions
- Diabetes Mellitus, Type 2, Coronary Restenosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Lantheus Medical ImagingIndustry (pharma, biotech, devices)
- Study start
- Apr 2004
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 13 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 clinical research study is determine if patients with diabetes that have undergone previous opening of a heart blockage may have a blockage that is not causing any symptoms that may be detected by imaging with Cardiolite.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Type II Diabetes on medication \& angioplasty within the past 6 months.
Key exclusion criteria (2 listed)
- Myocardial infarction or repeat angioplasty with the past 5 months.
- Unable to perform exercise or pharmacologic stress test.
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 |
|---|---|---|
| Technetium Tc99m Sestamibi | Drug | – |
Primary outcome
Evaluate symptom-free heart blockages that develop following initial opening in patients with Type II diabetes mellitus based on Cardiolite imaging
3 secondary outcomes
Determine how often symptom-free heart blockages occur 5-6 months after opening in patients with Type II diabetes mellitus
Examine the relative value of ejection fraction, summed stress, rest, and difference MPI scores for identifying patients with cardiac events during 18 month follow-up.
Compare patient hospital and out-patient cost for cardiac care for each group of patients (MPI versus standard care).
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 15 Apr 2011.
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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.
Qi Zhu, MD study director
Lantheus Medical Imaging
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Technetium Tc99m Sestamibi in people with Diabetes Mellitus, Type 2 and Coronary Restenosis, run by Lantheus Medical Imaging at 8 sites in 2 countries.
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 2 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 15 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Puerto Rico. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Evaluate symptom-free heart blockages that develop following initial opening in patients with Type II diabetes mellitus based on Cardiolite imaging. 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 15 Apr 2011.