Coronary AngioplastyPhase 3PTCA-NutriNCT01028066
Feeding Education in Patients Submitted to Coronary Angioplasty
A Phase 3 study testing Traditional and Behavioral in people with Coronary Angioplasty and Coronary Disease, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
The simple knowledge that practices healthy lifestyle are important to reduce or prevent the progression of cardiovascular diseases it is not enough for effective changes accordingly. To nutritional education be successful, needs to promote changes in eating habits and not just transmit information. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Angioplasty, Coronary Disease
- What is being tested?
- Traditional and Behavioral
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2008to Jan 2012
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- preserved cognitive status
Who cannot join
- no availability to attend the meetings of nutritional guidance
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Heart Institute of Clinics Hospital of Medicine Faculty of São Paulo University
São Paulo, São Paulo, 05403000
About this study
Official title: Feeding Education in Patients Submitted to Percutaneous Transluminal Coronary Angioplasty: Randomized Clinical Trial
The simple knowledge that practices healthy lifestyle are important to reduce or prevent the progression of cardiovascular diseases it is not enough for effective changes accordingly. To nutritional education be successful, needs to promote changes in eating habits and not just transmit information. This is a behavioral intervention study in 200 consecutive patients submitted to percutaneous transluminary coronary angioplasty. The participants were randomized in two groups: intervention and control.
The intervention was a dialogic nutritional counseling and the control arm was a traditional nutritional counseling.
All participants will undergo long-term follow-up for cardiovascular events.
Read the detailed description
Patients were hospitalized to realize elective coronary angioplasty in a especialized hospital in cardiovascular disease.
All data were obtained by a trained nutritionist.
- Conditions
- Coronary Angioplasty, Coronary Disease
- Being tested
- Traditional, Behavioral
- Keywords
- nutritional intervention, nutritional counseling, feeding behavior, food consumption, angioplasty
- Medical subject headings
- Coronary Disease, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TraditionalOther
The control group will have access to the nutritionist to clear any doubts about the diet prescribed when went out the hospital and will be invited to attend a meeting nutrition in dialogic character at the end of 1 year to ensure fairness in action.
BehavioralBehavioural
The intervention group will go through 4 meetings of food education, to be held within the institution, with approximately 1 hour long, composed of 3 to 8 patients, who may or may not be accompanied by a relative. The first three meetings will be monthly and the fourth will be 6 months after the last one. Each meeting will be developed within the context of dialogic and participatory education, directed to the adoption of a healthy diet and prevention and control of cardiovascular risk factors. The meetings will follow the order: Investigation, Contextualization, Awareness and Strengthening the nutritional concepts, according to the didactics of educator Paulo Freire.
| Study group | Role | What they receive |
|---|---|---|
| Traditional | Active comparator | Traditional nutritional counseling Receives: Other: Traditional |
| Behavioral | Experimental | Dialogic nutritional counseling Receives: Behavioral: Behavioral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular event (new ptca, cabg, ischemic acute syndrome, myocardial infarction) and mortality (all causes)
Measured: 1 year (all outcomes) and 3 years (all outcomes)
Secondary outcomes (1)
- Evaluate changes in eating habits, according to the transtheoretical model to adopt healthy eating habits - Check change in food intake - Identify the nutritional status and cardiovascular risk
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2009 (estimated)
- Study startApr 2008
- Primary completionAug 2009
- Study completionJan 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary AngioplastyStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe 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
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Investigators
- Moacyr Roberto Cucê Nobre, Principal investigator, Heart Institute HCFMUSP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01028066
- Sponsor's protocol ID
- CAPPesq 0443/07
- Other IDs
- FAPESP 2007/54652-8
- Acronym
- PTCA-Nutri
- Status last verified
- Dec 2009
- First submitted
- 8 Dec 2009
- Last updated
- 11 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feeding Education in Patients Submitted to Percutaneous Transluminal Coronary Angioplasty: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01028066
- Acronym / sponsor ID
- PTCA-Nutri / CAPPesq 0443/07
- Conditions
- Coronary Angioplasty, Coronary Disease
- Keywords
- nutritional intervention, nutritional counseling, feeding behavior, food consumption, angioplasty
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Apr 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Jan 2012 (estimated)
- First posted
- 9 Dec 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 simple knowledge that practices healthy lifestyle are important to reduce or prevent the progression of cardiovascular diseases it is not enough for effective changes accordingly. To nutritional education be successful, needs to promote changes in eating habits and not just transmit information. This is a behavioral intervention study in 200 consecutive patients submitted to percutaneous transluminary coronary angioplasty. The participants were randomized in two groups: intervention and control.
The intervention was a dialogic nutritional counseling and the control arm was a traditional nutritional counseling.
All participants will undergo long-term follow-up for cardiovascular events.
Detailed description
Patients were hospitalized to realize elective coronary angioplasty in a especialized hospital in cardiovascular disease.
All data were obtained by a trained nutritionist.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional | Active comparator | Other: TraditionalTraditional nutritional counseling |
| Behavioral | Experimental | Behavioral: BehavioralDialogic nutritional counseling |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- preserved cognitive status
Key exclusion criteria (1 listed)
- no availability to attend the meetings of nutritional guidance
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 |
|---|---|---|
| TraditionalThe control group will have access to the nutritionist to clear any doubts about the diet prescribed when went out the hospital and will be invited to attend a meeting nutrition in dialogic character at the end of 1 year to ensure fairness in action. | Other | Traditional |
| BehavioralThe intervention group will go through 4 meetings of food education, to be held within the institution, with approximately 1 hour long, composed of 3 to 8 patients, who may or may not be accompanied by a relative. The first three meetings will be monthly and the fourth will be 6 months after the last one. Each meeting will be developed within the context of dialogic and participatory education, directed to the adoption of a healthy diet and prevention and control of cardiovascular risk factors. The meetings will follow the order: Investigation, Contextualization, Awareness and Strengthening the nutritional concepts, according to the didactics of educator Paulo Freire. | Behavioural | Behavioral |
Primary outcome
Cardiovascular event (new ptca, cabg, ischemic acute syndrome, myocardial infarction) and mortality (all causes)
Time frame: 1 year (all outcomes) and 3 years (all outcomes)
1 secondary outcome
- Evaluate changes in eating habits, according to the transtheoretical model to adopt healthy eating habits - Check change in food intake - Identify the nutritional status and cardiovascular risk
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 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.
Moacyr Roberto Cucê Nobre principal investigator
Heart Institute HCFMUSP
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 Traditional and Behavioral in people with Coronary Angioplasty and Coronary Disease, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 1 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: status not confirmed, as of the sponsor's last update on 11 Dec 2009. 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 Brazil. 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?
Results are not available in the source record.
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?
Cardiovascular event (new ptca, cabg, ischemic acute syndrome, myocardial infarction) and mortality (all causes) (time frame: 1 year (all outcomes) and 3 years (all outcomes)). 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 Dec 2009.