Coronary Artery DiseaseNCT00967278
Hemodynamic Changes in Off-pump Coronary Artery Bypass Grafting
An observational study of Coronary Artery Disease, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The purpose of this study is to study the positioning and stabilization of different cardiac walls performed during off-pump coronary artery bypass grafting (CABG) may have dissimilar impact on hemodynamics. The objective is to evaluate hemodynamics during distal coronary anastomoses in different cardiac walls. Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- Coronary Artery Disease
- How many people
- Not given
- Where
- 1 siteBrazil
- Study dates
- Start not givento not given
- 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 Up to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with coronary artery disease indicated to elective surgical treatment
Who may be able to join
- Normal left ventricular function
- Minimal to moderate surgical risk according to criteria proposed by Higgins et al. (JAMA. 1992 May 6;267(17):2344-8)
Who cannot join
- Patients with a left ventricular ejection fraction <50%,
- Age >80 yr
- Creatinine >1.4 mg/dl
- Reoperation
- Valvular heart disease
- Chronic obstructive pulmonary disease
- High surgical risk according to criteria proposed by Higgins et al. (JAMA. 1992 May 6;267(17):2344-8)
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo, 05403-900
About this study
The purpose of this study is to study the positioning and stabilization of different cardiac walls performed during off-pump coronary artery bypass grafting (CABG) may have dissimilar impact on hemodynamics.
The objective is to evaluate hemodynamics during distal coronary anastomoses in different cardiac walls.
Read the detailed description
- Twenty patients undergoing off-pump CABG monitored with pulmonary artery catheter and esophageal doppler will be enrolled.
- Patients with a left ventricular ejection fraction <50%, age >80 yr, creatinine >1.4 mg/dl, reoperation, valvular heart disease or chronic obstructive pulmonary disease were excluded
- Data will be collected after volemic and hemodynamic adjustments, after heart positioning and establishment of a suction stabilizer and before its removal in anterior, lateral or posterior wall artery anastomosis.
- Data was compared by means of two-way repeated measures ANOVA.
- Conditions
- Coronary Artery Disease
- Keywords
- OPCAB, pulmonary artery catheter, esophageal doppler, hemodynamics
- Medical subject headings
- 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 |
|---|---|---|
| Off-Pump | Patients with coronary artery disease undergoing elective off-pump CABG |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2009 (estimated)
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 University of Sao PauloThe 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
- Cohort
- Time perspective
- Cross-sectional
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00967278
- Sponsor's protocol ID
- FAPESP 03/07092-6
- Status last verified
- Aug 2009
- First submitted
- 26 Aug 2009
- Last updated
- 1 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Changes in Off-pump Coronary Artery Bypass Grafting
- ClinicalTrials.gov ID
- NCT00967278
- Acronym / sponsor ID
- FAPESP 03/07092-6
- Conditions
- Coronary Artery Disease
- Keywords
- OPCAB, pulmonary artery catheter, esophageal doppler, hemodynamics
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- First posted
- 27 Aug 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 study the positioning and stabilization of different cardiac walls performed during off-pump coronary artery bypass grafting (CABG) may have dissimilar impact on hemodynamics.
The objective is to evaluate hemodynamics during distal coronary anastomoses in different cardiac walls.
Detailed description
- Twenty patients undergoing off-pump CABG monitored with pulmonary artery catheter and esophageal doppler will be enrolled.
- Patients with a left ventricular ejection fraction <50%, age >80 yr, creatinine >1.4 mg/dl, reoperation, valvular heart disease or chronic obstructive pulmonary disease were excluded
- Data will be collected after volemic and hemodynamic adjustments, after heart positioning and establishment of a suction stabilizer and before its removal in anterior, lateral or posterior wall artery anastomosis.
- Data was compared by means of two-way repeated measures ANOVA.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Off-Pump | – | –Patients with coronary artery disease undergoing elective off-pump CABG |
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with coronary artery disease indicated to elective surgical treatment
Key inclusion criteria (2 listed)
- Normal left ventricular function
- Minimal to moderate surgical risk according to criteria proposed by Higgins et al. (JAMA. 1992 May 6;267(17):2344-8)
Key exclusion criteria (7 listed)
- Patients with a left ventricular ejection fraction <50%,
- Age >80 yr
- Creatinine >1.4 mg/dl
- Reoperation
- Valvular heart disease
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
Not reported in the source record.
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 1 Sep 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.
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 Coronary Artery Disease, run by University of Sao Paulo 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 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 1 Sep 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.
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.
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 1 Sep 2009.