AtherosclerosisNCT00561028
Chlamydia and Mycoplasma in Coronary Artery Disease
An observational study of Atherosclerosis and Coronary Artery Disease, run by Hospital de Base.
Trial summary
To test the association between anti-Chlamydia serum titers and anti-Mycoplasma antibodies with Acute Coronary Syndromes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atherosclerosis, Coronary Artery Disease, Chlamydia Infections
- What is being tested?
- blood sample analysis - mycoplasma and chlamydia antibodies
- How many people
- 138 participants
- Where
- No sites listed yet
- Study dates
- Mar 2002to Nov 2004
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Group 1 and 2 - selected after admission in coronary care unit. Group 3 - selected from out-patient cardiology clinic. Group 4 - selected from the blood donation unit.
Who may be able to join
- Age >18 yrs
- Males and females
- Agreed to sign the informed consent
Who cannot join
- Refusal to sign the informed consent
- Follow-up not possible
- For the "acute" groups, time between the pain beginning and randomization >24 hours
- Active infections
- Use of antimicrobial agents within the last 30 days
- End-stage diseases with life expectancy <6 months
About this study
Official title: Prevalence of Chlamydia Pneumoniae and Mycoplasma Pneumoniae in Different Forms of Obstructive Coronary Artery Disease
To test the association between anti-Chlamydia serum titers and anti-Mycoplasma antibodies with Acute Coronary Syndromes.
Read the detailed description
One hundred and twenty-six patients were divided into 4 groups: Acute Coronary Syndrome with ST-elevation, Non-ST-elevation, stable coronary artery disease, and individuals without coronary disease. Anti-Chlamydia and anti-Mycoplasma IgG antibodies were measured at baseline and after 6 months.
- Being tested
- blood sample analysis - mycoplasma and chlamydia antibodies
- Keywords
- Atherosclerosis, Coronary artery disease, Chlamydia pneumoniae, Mycoplasma pneumoniae
- Medical subject headings
- Atherosclerosis, Coronary Artery Disease, Chlamydia Infections, Mycoplasma Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sample analysis - mycoplasma and chlamydia antibodiesOther
Anti-Chlamydia and anti-Mycoplasma IgG antibodies were measured by indirect immunofluorescence at baseline (24 hours of hospitalization) and after 6 months (follow-up).
| Study group | Role | What they receive |
|---|---|---|
| 1 | ST-elevation acute myocardial infarction. Receives: Other: blood sample analysis - mycoplasma and chlamydia antibodies | |
| 2 | high-risk unstable angina or non-ST-elevation myocardial infarction. Receives: Other: blood sample analysis - mycoplasma and chlamydia antibodies | |
| 3 | known coronary artery disease, either asymptomatic or with stable angina. Receives: Other: blood sample analysis - mycoplasma and chlamydia antibodies | |
| 4 | blood donors without known coronary artery disease. Receives: Other: blood sample analysis - mycoplasma and chlamydia antibodies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test the hypothesis that patients with acute coronary syndromes have higher levels of Chlamydia pneumonia and Mycoplasma pneumonia antibodies in comparison with patients with stable coronary artery disease or controls.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2007 (estimated)
- Study startMar 2002
- Study completionNov 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AtherosclerosisStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Base
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sao Paulo
- Investigators
- Jose C Nicolau, MD, pHD, Study director, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00561028
- Sponsor's protocol ID
- 5105/2001
- Other IDs
- 885/02
- Status last verified
- Nov 2007
- First submitted
- 19 Nov 2007
- Last updated
- 20 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Maia IL, Nicolau JC, Machado MN, Maia LN, Takakura IT, Rocha PR, Cordeiro JA, Ramires JA. Prevalence of Chlamydia pneumoniae and Mycoplasma pneumoniae in different forms of coronary disease. Arq Bras Cardiol. 2009 Jun;92(6):405-11, 422-8, 439-45. doi: 10.1590/s0066-782x2009000600005. English, Multiple languages.
PubMed 19629306
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Chlamydia Pneumoniae and Mycoplasma Pneumoniae in Different Forms of Obstructive Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT00561028
- Acronym / sponsor ID
- 5105/2001
- Keywords
- Atherosclerosis, Coronary artery disease, Chlamydia pneumoniae, Mycoplasma pneumoniae
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Hospital de BaseUniversity, hospital or other
- Collaborators
- University of Sao Paulo
- Study start
- Mar 2002
- Study completion
- Nov 2004 (actual)
- First posted
- 20 Nov 2007 (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.
To test the association between anti-Chlamydia serum titers and anti-Mycoplasma antibodies with Acute Coronary Syndromes.
Detailed description
One hundred and twenty-six patients were divided into 4 groups: Acute Coronary Syndrome with ST-elevation, Non-ST-elevation, stable coronary artery disease, and individuals without coronary disease. Anti-Chlamydia and anti-Mycoplasma IgG antibodies were measured at baseline and after 6 months.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: blood sample analysis - mycoplasma and chlamydia antibodiesST-elevation acute myocardial infarction. |
| 2 | – | Other: blood sample analysis - mycoplasma and chlamydia antibodieshigh-risk unstable angina or non-ST-elevation myocardial infarction. |
| 3 | – | Other: blood sample analysis - mycoplasma and chlamydia antibodiesknown coronary artery disease, either asymptomatic or with stable angina. |
| 4 | – | Other: blood sample analysis - mycoplasma and chlamydia antibodiesblood donors without known coronary artery disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Group 1 and 2 - selected after admission in coronary care unit. Group 3 - selected from out-patient cardiology clinic. Group 4 - selected from the blood donation unit.
Key inclusion criteria (3 listed)
- Age >18 yrs
- Males and females
- Agreed to sign the informed consent
Key exclusion criteria (6 listed)
- Refusal to sign the informed consent
- Follow-up not possible
- For the "acute" groups, time between the pain beginning and randomization >24 hours
- Active infections
- Use of antimicrobial agents within the last 30 days
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 |
|---|---|---|
| blood sample analysis - mycoplasma and chlamydia antibodiesAnti-Chlamydia and anti-Mycoplasma IgG antibodies were measured by indirect immunofluorescence at baseline (24 hours of hospitalization) and after 6 months (follow-up). | Other | 1, 2, 3, 4 |
Primary outcome
Test the hypothesis that patients with acute coronary syndromes have higher levels of Chlamydia pneumonia and Mycoplasma pneumonia antibodies in comparison with patients with stable coronary artery disease or controls.
Time frame: 6 months
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 20 Nov 2007.
- Derived from this study: PubMed 19629306Maia IL, Nicolau JC, Machado MN, Maia LN, Takakura IT, Rocha PR, Cordeiro JA, Ramires JA. Prevalence of Chlamydia pneumoniae and Mycoplasma pneumoniae in different forms of coronary disease. Arq Bras Cardiol. 2009 Jun;92(6):405-11, 422-8, 439-45. doi: 10.1590/s0066-782x2009000600005. English, Multiple languages.
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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.
Jose C Nicolau, MD, pHD study director
University of Sao Paulo
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerosis and Coronary Artery Disease, run by Hospital de Base.
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 6 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 20 Nov 2007. 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?
Test the hypothesis that patients with acute coronary syndromes have higher levels of Chlamydia pneumonia and Mycoplasma pneumonia antibodies in comparison with patients with stable coronary artery disease or controls. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00561028, which also lists 1 linked publication.
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 20 Nov 2007.