DiabetesNCT03338153
Evaluation of Long-term Coronary Stenting Outcomes in Diabetic Patients With or Without Optimal Glycemic Control
An observational study of Diabetes and Coronary Artery Disease, run by Tehran Heart Center at 1 site in Iran.
Trial summary
the purpose of this study is to determine whether appropriate control of diabetes around the PCI time is related with MACE and outcome of diabetic patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes, Coronary Artery Disease
- How many people
- 1,353 participants
- Where
- 1 siteIran
- Study dates
- Oct 2007to Mar 2013
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients undergoing per-cutaneous coronary intervention between October 2007 and December 2009
Who may be able to join
- age between 18-75
- coronary stenosis > 70%
Who cannot join
- Myocardial infarction in 72 hours prior to PCI
- LVEF < 30%
- Residual Stenosis>30%
- Cr level > 2.0
- hemodynamic compromise during intervention
- Left main lesions
- PCI for vein grafts
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Long-term Coronary Stenting Outcomes in Diabetic Patients With or Without Optimal Glycemic Control Referring to Tehran Heart Center Since June 2007 to June 2009
the purpose of this study is to determine whether appropriate control of diabetes around the PCI time is related with MACE and outcome of diabetic patients.
Read the detailed description
Despite recent advances in coronary revascularization, cardiovascular disease accounts for about 75% of all hospital admissions in diabetic patients.although the introduction of drug-eluting stents has reduced the rates of restenosis after PCI, diabetic patients undergoing PCI will have poorer clinical outcomes.In this study, we sought to investigate whether a pre and post procedural glycemic control in diabetic patients,as reflected by HgbA1C prior,1 and 6 months after elective PCI,was related to major advance cardiac events (MACE) during 3 year follow up.
- Conditions
- Diabetes, Coronary Artery Disease
- Medical subject headings
- Diabetes Mellitus, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| controlled diabetes | diabetic patients with HbA1C level below 7.0% | |
| uncontrolled diabetes | diabetic patients with hbA1C level above 7% | |
| non-diabetic | patients who does not have diabetes at the time of PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiac event
Measured: during 3 years after per-cutaneous coronary intervention
Secondary outcomes (2)
target vessel revascularization
Measured: during 3 years after PCI
target lesion revascularization
Measured: during 3 years after PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2017
- Study startOct 2007
- Primary completionDec 2009
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- 1,353 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tehran Heart Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ebrahim kassaian, MD, Principal investigator, Tehran Heart Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03338153
- Sponsor's protocol ID
- TUMS-90-04-30-15887
- Status last verified
- Nov 2017
- First submitted
- 7 Nov 2017
- Last updated
- 9 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Long-term Coronary Stenting Outcomes in Diabetic Patients With or Without Optimal Glycemic Control Referring to Tehran Heart Center Since June 2007 to June 2009
- ClinicalTrials.gov ID
- NCT03338153
- Acronym / sponsor ID
- TUMS-90-04-30-15887
- Conditions
- Diabetes, Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,353 participants (actual)
- Lead sponsor
- Tehran Heart CenterUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 9 Nov 2017 (actual)
- 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 determine whether appropriate control of diabetes around the PCI time is related with MACE and outcome of diabetic patients.
Detailed description
Despite recent advances in coronary revascularization, cardiovascular disease accounts for about 75% of all hospital admissions in diabetic patients.although the introduction of drug-eluting stents has reduced the rates of restenosis after PCI, diabetic patients undergoing PCI will have poorer clinical outcomes.In this study, we sought to investigate whether a pre and post procedural glycemic control in diabetic patients,as reflected by HgbA1C prior,1 and 6 months after elective PCI,was related to major advance cardiac events (MACE) during 3 year follow up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| controlled diabetes | – | –diabetic patients with HbA1C level below 7.0% |
| uncontrolled diabetes | – | –diabetic patients with hbA1C level above 7% |
| non-diabetic | – | –patients who does not have diabetes at the time of PCI |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing per-cutaneous coronary intervention between October 2007 and December 2009
Key inclusion criteria (2 listed)
- age between 18-75
- coronary stenosis > 70%
Key exclusion criteria (7 listed)
- Myocardial infarction in 72 hours prior to PCI
- LVEF < 30%
- Residual Stenosis>30%
- Cr level > 2.0
- hemodynamic compromise during intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Major adverse cardiac event
Time frame: during 3 years after per-cutaneous coronary intervention
2 secondary outcomes
target vessel revascularization
Time frame: during 3 years after PCI
target lesion revascularization
Time frame: during 3 years after PCI
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 9 Nov 2017.
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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.
Ebrahim kassaian, MD principal investigator
Tehran Heart Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Coronary Artery Disease, run by Tehran Heart Center at 1 site in Iran.
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 7 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 9 Nov 2017. 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 Iran. 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?
Major adverse cardiac event (time frame: during 3 years after per-cutaneous 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 9 Nov 2017.