Degenerative Cardiac Valve DiseaseNCT01409525
Rate of Microbial Colonization Over Native Calcified Cardiac Valves
An observational study of Degenerative Cardiac Valve Disease and Coronary Artery Bypass Surgery Patients, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
The purpose of this observational, exploratory study in patients undergoing any cardiac valve replacement or repair is to assess the rate of bacterial colonization over native degenerative calcified cardiac valves. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Degenerative Cardiac Valve Disease, Coronary Artery Bypass Surgery Patients
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2011to Oct 2012
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Up to 200 eligible adult subjects, scheduled to undergo elective cardiac surgery in RAMBAM medical center.
Who may be able to join
- Written informed consent must be obtained from the subject or his/her legal guardian before any assessment is performed
- Male or Female subject, 50 years or older
- Subjects are scheduled to go through any cardiac valve replacement or repair due to degenerative calcified process. For control, subjects with no evidence of valve disease
Who cannot join
- Subjects have an established or indicated history of IE.
- Subjects have complaint that might indicate IE- intermittent fever and physical finding according to IE diagnosis criteria (not including a heart murmur)
- Subjects are current users or have a close history of drug abuse
Trial locations and contacts
1 site in 1 country.
Israel1 site
Rambam health care campus
Haifa
Liran Shani, MD, 972-4-8542631, l_shani@rambam.health.gov.il
Liran Shani, MD
About this study
Official title: Observational, Prospective, Exploratory Study to Evaluate the Rate of Microbial Colonization Over Native Calcified Cardiac Valves
The purpose of this observational, exploratory study in patients undergoing any cardiac valve replacement or repair is to assess the rate of bacterial colonization over native degenerative calcified cardiac valves.
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 |
|---|---|---|
| cardiac surgery patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
To asses the rate of bacterial colonization over degenerative cardiac valves and to discover whether there is a link to a specific micro-organism.
Measured: Patients will be followed for the duration of their hospitalization, average of 5 days.
Secondary outcomes (1)
Correlation between baseline demographic, clinical and laboratory parameters to degenerative cardiac valve disease
Baseline demographic, clinical and laboratory parameters such as age, gender, medical history, complete blood count and biochemistry profile will be compared between research group (degenerative cardiac valve disease) and control group (Isolated coronary artery bypass graft surgery patients) by means of multivariate analysis and pattern recognition techniques.
Measured: Patients will be followed for the duration of their hospitalization, average of 5 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionJul 2012 (estimated)
- Study completionOct 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Cardiac Valve DiseaseStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Investigators
- Liran Shani, MD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01409525
- Sponsor's protocol ID
- RMB-0233.CTIL
- Status last verified
- Aug 2011
- First submitted
- 28 Jul 2011
- Last updated
- 4 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational, Prospective, Exploratory Study to Evaluate the Rate of Microbial Colonization Over Native Calcified Cardiac Valves
- ClinicalTrials.gov ID
- NCT01409525
- Acronym / sponsor ID
- RMB-0233.CTIL
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Oct 2012 (estimated)
- First posted
- 4 Aug 2011 (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 observational, exploratory study in patients undergoing any cardiac valve replacement or repair is to assess the rate of bacterial colonization over native degenerative calcified cardiac valves.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cardiac surgery patients | – | – |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Up to 200 eligible adult subjects, scheduled to undergo elective cardiac surgery in RAMBAM medical center.
Key inclusion criteria (3 listed)
- Written informed consent must be obtained from the subject or his/her legal guardian before any assessment is performed
- Male or Female subject, 50 years or older
- Subjects are scheduled to go through any cardiac valve replacement or repair due to degenerative calcified process. For control, subjects with no evidence of valve disease
Key exclusion criteria (3 listed)
- Subjects have an established or indicated history of IE.
- Subjects have complaint that might indicate IE- intermittent fever and physical finding according to IE diagnosis criteria (not including a heart murmur)
- Subjects are current users or have a close history of drug abuse
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
To asses the rate of bacterial colonization over degenerative cardiac valves and to discover whether there is a link to a specific micro-organism.
Time frame: Patients will be followed for the duration of their hospitalization, average of 5 days.
1 secondary outcome
Correlation between baseline demographic, clinical and laboratory parameters to degenerative cardiac valve disease
Time frame: Patients will be followed for the duration of their hospitalization, average of 5 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2011.
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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.
Liran Shani, MD principal investigator
Rambam Health Care Campus
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 Degenerative Cardiac Valve Disease and Coronary Artery Bypass Surgery Patients, run by Rambam Health Care Campus at 1 site in Israel.
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 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: status not confirmed, as of the sponsor's last update on 4 Aug 2011. 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 Israel. 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 Liran Shani, MD (972-8542631, l_shani@rambam.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To asses the rate of bacterial colonization over degenerative cardiac valves and to discover whether there is a link to a specific micro-organism. (time frame: Patients will be followed for the duration of their hospitalization, average of 5 days.). 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 4 Aug 2011.