Chlamydia and Mycoplasma in Coronary Artery Disease

This study has been completed.
Sponsor:
Collaborator:
University of Sao Paulo
Information provided by:
Hospital de Base
ClinicalTrials.gov Identifier:
NCT00561028
First received: November 19, 2007
Last updated: NA
Last verified: November 2007
History: No changes posted
  Purpose

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


Condition Intervention
Atherosclerosis
Coronary Artery Disease
Chlamydia Infections
Mycoplasma Infections
Other: blood sample analysis - mycoplasma and chlamydia antibodies

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Prevalence of Chlamydia Pneumoniae and Mycoplasma Pneumoniae in Different Forms of Obstructive Coronary Artery Disease

Resource links provided by NLM:


Further study details as provided by Hospital de Base:

Primary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples Without DNA

Blood sample - serum


Enrollment: 138
Study Start Date: March 2002
Study Completion Date: November 2004
Groups/Cohorts Assigned Interventions
1
ST-elevation acute myocardial infarction.
Other: blood sample analysis - mycoplasma and chlamydia antibodies
Anti-Chlamydia and anti-Mycoplasma IgG antibodies were measured by indirect immunofluorescence at baseline (24 hours of hospitalization) and after 6 months (follow-up).
2
high-risk unstable angina or non-ST-elevation myocardial infarction.
Other: blood sample analysis - mycoplasma and chlamydia antibodies
Anti-Chlamydia and anti-Mycoplasma IgG antibodies were measured by indirect immunofluorescence at baseline (24 hours of hospitalization) and after 6 months (follow-up).
3
known coronary artery disease, either asymptomatic or with stable angina.
Other: blood sample analysis - mycoplasma and chlamydia antibodies
Anti-Chlamydia and anti-Mycoplasma IgG antibodies were measured by indirect immunofluorescence at baseline (24 hours of hospitalization) and after 6 months (follow-up).
4
blood donors without known coronary artery disease.
Other: blood sample analysis - mycoplasma and chlamydia antibodies
Anti-Chlamydia and anti-Mycoplasma IgG antibodies were measured by indirect immunofluorescence at baseline (24 hours of hospitalization) and after 6 months (follow-up).

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00561028

Sponsors and Collaborators
Hospital de Base
University of Sao Paulo
Investigators
Study Director: Jose C Nicolau, MD, pHD University of Sao Paulo
  More Information

No publications provided by Hospital de Base

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00561028     History of Changes
Other Study ID Numbers: 5105/2001, 885/02
Study First Received: November 19, 2007
Last Updated: November 19, 2007
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Hospital de Base:
Atherosclerosis
Coronary artery disease
Chlamydia pneumoniae
Mycoplasma pneumoniae

Additional relevant MeSH terms:
Atherosclerosis
Chlamydia Infections
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Pleuropneumonia
Mycoplasma Infections
Pneumonia, Mycoplasma
Pneumonia
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Sexually Transmitted Diseases
Infection
Genital Diseases, Male
Genital Diseases, Female
Heart Diseases
Lung Diseases
Respiratory Tract Diseases
Pleurisy
Pleural Diseases
Respiratory Tract Infections
Mycoplasmatales Infections
Pneumonia, Bacterial
Antibodies

ClinicalTrials.gov processed this record on July 24, 2014