Cardiovascular DiseasePhase 3NCT00408577
Prevention of Cardiac and Vascular Events in Patients With NGT/IGT.
A Phase 3 study testing L-arginine in people with Cardiovascular Disease, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
Impaired glucose tolerance or mild glucose elevations in the non-diabetic range are associated with increased cardiovascular disease and recent studies suggested the need to detect these glucose abnormalities early in the post-infarction period. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- L-arginine
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2004to Nov 2006
- Phase
- Phase 3
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients in stable clinical conditions after coronary revascularization (CABG and percutaneous angioplasty with/without stent implantation).
- Age > 30 years, male and female.
- Fasting glucose levels below 126 mg/dl.
Who cannot join
- Type 1 diabetes mellitus,
- known type 2 diabetes mellitus,
- pregnancy,
- impaired kidney and liver function,
- severe and not treated arterial hypertension.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention of Cardiovascular Relapses by L-Arginine Oral Administration in Patients With CAD and IGT and/or Insulin Resistance.
Impaired glucose tolerance or mild glucose elevations in the non-diabetic range are associated with increased cardiovascular disease and recent studies suggested the need to detect these glucose abnormalities early in the post-infarction period. Although in the last ten years procedures of coronary revascularisation have dramatically improved the outcome of non diabetic patients affected by ischemic heart disease, these procedures are less effective in patients with type 2 diabetes mellitus and IGT. Possible causes of worse prognosis in these patients could be related to the presence of hyperinsulinemia and insulin resistance due to the well known effect of insulin to increase neointimal tissue proliferation and in-stent restenosis, by stimulating vascular smooth muscle cell growth factors and migration. In addition, it is well known that endothelial dysfunction is an early functional disturbance in the development of atherosclerotic lesions. The impairment of eNOS action might change the turnover rate of eNOS or nitric oxide production and action influencing nitric oxide signalling, apoptosis cascade and angiogenesis. All these factors can contribute to endothelial dysfunction to a certain extent, and accelerate atherosclerosis with increased risk for cardiovascular disease.
The constitutively expressed eNOS, is likely to be the major contributors to whole-body nitric oxide production. It is interesting to note that a region of chromosome 7q seems to influence both insulin resistance and blood pressure, suggesting that this locus may broadly influence traits associated with insulin resistance.
Read more
L-arginine is an essential amino acid and its availability is important for the normal endothelial cell function and its intracellular reduction may contribute to the dysfunctional endothelial state. It is well known that L-arginine is as a precursor for nitric oxide and both in vitro and in vivo studies have demonstrated that L-arginine can augment vascular dilation under certain conditions.
Our hypothesis is to evaluate the modulating effect of L-arginine on metabolic, endothelial variables and on myocardial function in patients with cardiovascular disease.
Read the detailed description
Condition: Patients submitted to coronary revascularization characterized for glucose tolerance after OGTT Intervention: L-arginine for 6 months Inclusion criteria: patients in stable clinical conditions after coronary revascularization (CABG and percutaneous angioplasty with/without stent implantation). Age > 30 years, male and female. Fasting glucose levels below 126 mg/dl.
Exclusion criteria. Type 1 diabetes mellitus, known type 2 diabetes mellitus, pregnancy, impaired kidney and liver function, severe and not treated arterial hypertension.
Study type: randomized, double blind, Placebo, parallel
- Conditions
- Cardiovascular Disease
- Being tested
- L-arginine
- Keywords
- glucose intolerance, cardiovascular disease, insulin resistance, endothelial dysfunction
- Medical subject headings
- Cardiovascular Diseases, Glucose Intolerance, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-arginineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of 6 months L-arginine/placebo oral treatment on glucose tolerance and insulin resistance measured by OGTT
Secondary outcomes (1)
Evaluation of 6 months L-arginine/placebo oral treatment on endothelial function
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2006 (estimated)
- Study startNov 2004
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 150 participants
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Investigators
- PierMarco Piatti, MD, Principal investigator, Scientific Institute San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00408577
- Sponsor's protocol ID
- OSRAFFA_III_2004_003
- Status last verified
- Dec 2006
- First submitted
- 6 Dec 2006
- Last updated
- 12 Dec 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Cardiovascular Relapses by L-Arginine Oral Administration in Patients With CAD and IGT and/or Insulin Resistance.
- ClinicalTrials.gov ID
- NCT00408577
- Acronym / sponsor ID
- OSRAFFA_III_2004_003
- Conditions
- Cardiovascular Disease
- Keywords
- glucose intolerance, cardiovascular disease, insulin resistance, endothelial dysfunction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- Nov 2004
- Study completion
- Nov 2006
- First posted
- 7 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.
Impaired glucose tolerance or mild glucose elevations in the non-diabetic range are associated with increased cardiovascular disease and recent studies suggested the need to detect these glucose abnormalities early in the post-infarction period. Although in the last ten years procedures of coronary revascularisation have dramatically improved the outcome of non diabetic patients affected by ischemic heart disease, these procedures are less effective in patients with type 2 diabetes mellitus and IGT. Possible causes of worse prognosis in these patients could be related to the presence of hyperinsulinemia and insulin resistance due to the well known effect of insulin to increase neointimal tissue proliferation and in-stent restenosis, by stimulating vascular smooth muscle cell growth factors and migration. In addition, it is well known that endothelial dysfunction is an early functional disturbance in the development of atherosclerotic lesions. The impairment of eNOS action might change the turnover rate of eNOS or nitric oxide production and action influencing nitric oxide signalling, apoptosis cascade and angiogenesis. All these factors can contribute to endothelial dysfunction to a certain extent, and accelerate atherosclerosis with increased risk for cardiovascular disease.
The constitutively expressed eNOS, is likely to be the major contributors to whole-body nitric oxide production. It is interesting to note that a region of chromosome 7q seems to influence both insulin resistance and blood pressure, suggesting that this locus may broadly influence traits associated with insulin resistance.
L-arginine is an essential amino acid and its availability is important for the normal endothelial cell function and its intracellular reduction may contribute to the dysfunctional endothelial state. It is well known that L-arginine is as a precursor for nitric oxide and both in vitro and in vivo studies have demonstrated that L-arginine can augment vascular dilation under certain conditions.
Our hypothesis is to evaluate the modulating effect of L-arginine on metabolic, endothelial variables and on myocardial function in patients with cardiovascular disease.
Detailed description
Condition: Patients submitted to coronary revascularization characterized for glucose tolerance after OGTT Intervention: L-arginine for 6 months Inclusion criteria: patients in stable clinical conditions after coronary revascularization (CABG and percutaneous angioplasty with/without stent implantation). Age > 30 years, male and female. Fasting glucose levels below 126 mg/dl.
Exclusion criteria. Type 1 diabetes mellitus, known type 2 diabetes mellitus, pregnancy, impaired kidney and liver function, severe and not treated arterial hypertension.
Study type: randomized, double blind, Placebo, parallel
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients in stable clinical conditions after coronary revascularization (CABG and percutaneous angioplasty with/without stent implantation).
- Age > 30 years, male and female.
- Fasting glucose levels below 126 mg/dl.
Key exclusion criteria (5 listed)
- Type 1 diabetes mellitus,
- known type 2 diabetes mellitus,
- pregnancy,
- impaired kidney and liver function,
- severe and not treated arterial hypertension.
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 |
|---|---|---|
| L-arginine | Drug | – |
Primary outcome
Evaluation of 6 months L-arginine/placebo oral treatment on glucose tolerance and insulin resistance measured by OGTT
1 secondary outcome
Evaluation of 6 months L-arginine/placebo oral treatment on endothelial function
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 12 Dec 2006.
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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.
PierMarco Piatti, MD principal investigator
Scientific Institute San Raffaele
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing L-arginine in people with Cardiovascular Disease, run by IRCCS San Raffaele at 1 site in Italy.
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 5 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 12 Dec 2006. 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 Italy. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Evaluation of 6 months L-arginine/placebo oral treatment on glucose tolerance and insulin resistance measured by OGTT. 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 12 Dec 2006.