Genetic PolymorphismNCT00730899
Association Study of Gene Polymorphisms With Cardiac Performance
An observational study of Genetic Polymorphism and Coronary Artery Disease, run by University Hospital, Essen at 1 site in Germany.
Trial summary
The purpose of this study is to determine whether polymorphisms in G protein subunits, namely Galphas and Galphaq, are associated with altered cardiac performance in heart failure patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Genetic Polymorphism, Coronary Artery Disease, Hemodynamics
- How many people
- 500 participants
- Where
- 1 siteGermany
- Study dates
- May 2008to Jun 2011
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with coronary artery disease scheduled for coronary artery bypass grafting in the university hospital
Who may be able to join
- clinical diagnosis of coronary artery disease
- patients scheduled for coronary artery bypass grafting
Who cannot join
- emergency operation
- combined vitium
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital
Essen, North Rhine-Westphalia, 45147
Ulrich H Frey, MD, +49201723 ext. 1401, ulrich.frey@uk-essen.de
Jürgen Peters, MD
About this study
Official title: Observational Association Study of G Protein Polymorphisms With Cardiac Performance in Coronary Artery Disease Patients Undergoing Coronary Artery Bypass Grafting
The purpose of this study is to determine whether polymorphisms in G protein subunits, namely Galphas and Galphaq, are associated with altered cardiac performance in heart failure patients.
Read the detailed description
G Protein pathways plays a pivotal role in mediating positive inotropy and cardiac hypertrophy by transducing signals of neurohormones in cardiomyocytes. Single nucleotide polymorphisms (SNPs) in the G protein subunits Galphas and Galphaq have been shown to result in altered protein expression. We now want to examine whether G Protein polymorphisms alter NYHA functional class, and hemodynamic variables in patients with coronary artery disease scheduled for coronary artery bypass grafting .
- Conditions
- Genetic Polymorphism, Coronary Artery Disease, Hemodynamics
- Medical subject headings
- Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
genotype dependent change of hemodynamic variables
Measured: one day
Secondary outcomes (1)
all cause mortality
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2008 (estimated)
- Study startMay 2008
- Primary completionJan 2011 (estimated)
- Study completionJun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genetic PolymorphismStudies 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Essen
- Sponsor type
- University, hospital or other
- Investigators
- Jürgen Peters, MD, Study director, University Hospital, Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00730899
- Sponsor's protocol ID
- HOT-001
- Status last verified
- Aug 2008
- First submitted
- 4 Aug 2008
- Last updated
- 8 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Association Study of G Protein Polymorphisms With Cardiac Performance in Coronary Artery Disease Patients Undergoing Coronary Artery Bypass Grafting
- ClinicalTrials.gov ID
- NCT00730899
- Acronym / sponsor ID
- HOT-001
- Conditions
- Genetic Polymorphism, Coronary Artery Disease, Hemodynamics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Hospital, EssenUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Jan 2011 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 8 Aug 2008 (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 determine whether polymorphisms in G protein subunits, namely Galphas and Galphaq, are associated with altered cardiac performance in heart failure patients.
Detailed description
G Protein pathways plays a pivotal role in mediating positive inotropy and cardiac hypertrophy by transducing signals of neurohormones in cardiomyocytes. Single nucleotide polymorphisms (SNPs) in the G protein subunits Galphas and Galphaq have been shown to result in altered protein expression. We now want to examine whether G Protein polymorphisms alter NYHA functional class, and hemodynamic variables in patients with coronary artery disease scheduled for coronary artery bypass grafting .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with coronary artery disease scheduled for coronary artery bypass grafting in the university hospital
Key inclusion criteria (2 listed)
- clinical diagnosis of coronary artery disease
- patients scheduled for coronary artery bypass grafting
Key exclusion criteria (2 listed)
- emergency operation
- combined vitium
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
genotype dependent change of hemodynamic variables
Time frame: one day
1 secondary outcome
all cause mortality
Time frame: 60 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2008.
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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.
Jürgen Peters, MD study director
University Hospital, Essen
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 Genetic Polymorphism and Coronary Artery Disease, run by University Hospital, Essen at 1 site in Germany.
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 2 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 8 Aug 2008. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ulrich H Frey, MD (+49201723 ext. 1401, ulrich.frey@uk-essen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
genotype dependent change of hemodynamic variables (time frame: one day). 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 8 Aug 2008; AzTrials last refreshed its copy on 1 Nov 2026.