Coronary Artery DiseaseNCT00917930
Evaluation Rehabilitation on Glycometabolic State in Non-Diabetic Coronary Artery Disease (CAD) Patients
An observational study of Coronary Artery Disease, run by IRCCS San Raffaele.
Trial summary
The purpose of this study is to evaluate the effects of an intensive Cardiac rehabilitation program on glucose metabolism of non-diabetic coronary artery disease patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- physical training
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jan 2006to Jan 2007
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: non diabetes patients with coronary artery disease
Who may be able to join
- patients admitted to undergo a cycle of in-hospital cardiac rehabilitation
- patients without a previous diagnosis of diabetes mellitus
- patients able to start physical training within three days from admission
- fasting blood glucose at admission < 126 mg/dl
Who cannot join
- previous diagnosis of diabetes mellitus
- acute coronary events or acute heart failure in the past three months
- physical disabilities that contraindicate training
About this study
Official title: Effect of Cardiac Rehabilitation on Glucometabolic State in Non-Diabetic Patients With Chronic Ischemic Heart Disease
The purpose of this study is to evaluate the effects of an intensive Cardiac rehabilitation program on glucose metabolism of non-diabetic coronary artery disease patients.
- Conditions
- Coronary Artery Disease
- Being tested
- physical training
- Keywords
- exercise training, functional recovery, heart diseases, altered glucose metabolism early after an acute cardiac event, non diabetes CAD patients, glycometabolic state
- Medical subject headings
- Coronary Artery Disease, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical trainingBehavioural
intensive cardiac rehabilitation program
| Study group | Role | What they receive |
|---|---|---|
| physical training | Not described Receives: Behavioral: physical training |
What is being measured
The primary outcome is the main question the study is designed to answer.
to evaluate the effective prevalence of glucose metabolism alterations in patients with chronic ischemic heart disease and stable chronic heart failure, without previous diagnosis of diabetes mellitus
Secondary outcomes (1)
to evaluate the potential beneficial effect of physical training on the glycometabolic state
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2009 (estimated)
- Study startJan 2006
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00917930
- Sponsor's protocol ID
- 090505
- Status last verified
- Jun 2009
- First submitted
- 2 Jun 2009
- Last updated
- 11 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cardiac Rehabilitation on Glucometabolic State in Non-Diabetic Patients With Chronic Ischemic Heart Disease
- ClinicalTrials.gov ID
- NCT00917930
- Acronym / sponsor ID
- 090505
- Conditions
- Coronary Artery Disease
- Keywords
- exercise training, functional recovery, heart diseases, altered glucose metabolism early after an acute cardiac event, non diabetes CAD patients, glycometabolic state
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- Jan 2006
- Study completion
- Jan 2007 (actual)
- First posted
- 11 Jun 2009 (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 study is to evaluate the effects of an intensive Cardiac rehabilitation program on glucose metabolism of non-diabetic coronary artery disease patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| physical training | – | Behavioral: physical training |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- non diabetes patients with coronary artery disease
Key inclusion criteria (4 listed)
- patients admitted to undergo a cycle of in-hospital cardiac rehabilitation
- patients without a previous diagnosis of diabetes mellitus
- patients able to start physical training within three days from admission
- fasting blood glucose at admission < 126 mg/dl
Key exclusion criteria (3 listed)
- previous diagnosis of diabetes mellitus
- acute coronary events or acute heart failure in the past three months
- physical disabilities that contraindicate training
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 |
|---|---|---|
| physical trainingintensive cardiac rehabilitation program | Behavioural | physical training |
Primary outcome
to evaluate the effective prevalence of glucose metabolism alterations in patients with chronic ischemic heart disease and stable chronic heart failure, without previous diagnosis of diabetes mellitus
1 secondary outcome
to evaluate the potential beneficial effect of physical training on the glycometabolic state
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 11 Jun 2009.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by IRCCS San Raffaele.
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 4 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 11 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
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?
to evaluate the effective prevalence of glucose metabolism alterations in patients with chronic ischemic heart disease and stable chronic heart failure, without previous diagnosis of diabetes mellitus. 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 11 Jun 2009.