Chlamydia and Mycoplasma in Coronary Artery Disease

NCT00561028 | Completed

• 2 other identifiers: 5105/2001885/02
• Study Type: observational
• Target: 138
• Locations: 0 countries
• Sites: N/A

Brief Summary

To test the association between anti-Chlamydia serum titers and anti-Mycoplasma antibodies with Acute Coronary Syndromes.

Conditions

Atherosclerosis; Coronary Artery Disease; Chlamydia Infections; Mycoplasma Infections

Keywords

Atherosclerosis; Coronary artery disease; Chlamydia pneumoniae; Mycoplasma pneumoniae

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Study Arms (4)

1

ST-elevation acute myocardial infarction.

Other: blood sample analysis - mycoplasma and chlamydia antibodies

2

high-risk unstable angina or non-ST-elevation myocardial infarction.

Other: blood sample analysis - mycoplasma and chlamydia antibodies

3

known coronary artery disease, either asymptomatic or with stable angina.

Other: blood sample analysis - mycoplasma and chlamydia antibodies

4

blood donors without known coronary artery disease.

Other: blood sample analysis - mycoplasma and chlamydia antibodies

Interventions

blood sample analysis - mycoplasma and chlamydia antibodies OTHER

Anti-Chlamydia and anti-Mycoplasma IgG antibodies were measured by indirect immunofluorescence at baseline (24 hours of hospitalization) and after 6 months (follow-up).

1; 2; 3; 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• Age \>18 yrs
• Males and females
• Agreed to sign the informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital de Base: lead
• University of Sao Paulo: collaborator

Related Publications (1)

• 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.

  PMID: 19629306 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample - serum

MeSH Terms

Conditions

Atherosclerosis; Coronary Artery Disease; Chlamydia Infections; Mycoplasma Infections

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Chlamydiaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases; Mycoplasmatales Infections

Study Officials

• Jose C Nicolau, MD, pHD

  University of Sao Paulo

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 19, 2007
• First Posted: November 20, 2007
• Study Start: March 1, 2002
• Study Completion: November 1, 2004
• Last Updated: November 20, 2007

Record last verified: 2007-11