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Can Platelets/Lymphocytes Rate Be New Serological Index for Prognosis of Coronary Heart Disease Complicated With Impaired Glucose Tolerance: Basic Principles and Experimental Design

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ClinicalTrials.gov Identifier: NCT02149056
Recruitment Status : Completed
First Posted : May 29, 2014
Last Update Posted : May 29, 2014
Sponsor:
Information provided by (Responsible Party):
Ke-Ye Liu, Affiliated Hospital of Hebei University

Brief Summary:

Background About 2/3 patients of coronary heart disease (CHD) are complicated with disorder of carbohydrate metabolism which results in hyperglycemia and subsequent abnormality of coagulation system and inflammation. These patients have serious coronary artery pathology, multiple complications and poor prognosis. Platelets and lymphocytes play important roles in the occurrence and progression of atherosclerosis. The platelet/lymphocyte rate (PLR) is one simple hematological index. Previous studies confirmed that PLR could predict the long-term mortality of non-ST elevated myocardial infarction (NSTEMI). If simple hematological index could predict the prognosis of such kind of patients, it will provide new thought for early diagnosis and treatment in future. Therefore, the present study try to investigate if PLR could predict the poor prognosis of CHD patients complicated with impaired glucose tolerance (IGT) through calculating PLR.

Methods/design The present study is performed with strategy of an observational and prospective single-centre cohort. These patients are recruited from August 2013 to August 2014, according to the inclusion criteria of CHD complicated with IGT. CHD is confirmed with coronary angiography while IGT is determined according to the WHO criteria (1999). Routine blood test and serum glucose data of patients are acquired before hospitalization and surgery. According to the median of PLR after admission, the patients are divided into 3 groups. The patients are followed up for half, 1 and 3 years, respectively. The major clinical endpoint is mortality. The minor clinical endpoint indices are the correlations of PLR with MACE (including mortality, recurrent rate of infarction and reperfusion rate of target vessels), recurrent infarction, re-perfusion rate of target vessel, intra-stand thrombogenesis, stroke and acute onset of heart failure. The correlations are analyzed with receiver operating characteristics (ROC) survival curve and Kaplan-Meier survival analysis to find optimal prognosis index.

Summary Through regression analysis of long-term follow-up of patients, it is expected to find optimal predicting index of prognosis. While judging whether PLR is effective, other possible factors for new predictor are sought in order to provide help for future study.


Condition or disease Intervention/treatment
Coronary Heart Disease Complicated With Impaired Glucose Tolerance Behavioral: observation Other: Impaired Glucose Tolerance

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Study Type : Observational
Actual Enrollment : 447 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Can Platelets/Lymphocytes Rate Be New Serological Index for Prognosis of Coronary Heart Disease Complicated With Impaired Glucose Tolerance: Basic Principles and Experimental Design
Study Start Date : August 2013
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Group/Cohort Intervention/treatment
Impaired Glucose Tolerance Behavioral: observation
Other: Impaired Glucose Tolerance
Impaired Glucose Tolerance




Primary Outcome Measures :
  1. All cause mortality [ Time Frame: One year ]

Secondary Outcome Measures :
  1. correlations of PLR with MACE (including mortality, recurrent rate of infarction and reperfusion rate of target vessels) [ Time Frame: one year ]

Other Outcome Measures:
  1. recurrent infarction, re-perfusion rate of target vessel, intra-stand thrombogenesis, stroke and acute onset of heart failure [ Time Frame: one year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

1. Inclusion criteria:

  1. confirmed CHD by coronary angiography
  2. IGT according to WHO standard (1999) as fasting blood-glucose of 6.1~7.0mmol/L and blood-glucose of 7.8~11.1mmol/L at 2 h after oral administration of 75g glucose
  3. accessible complete data of routine blood test and serum glucose before admission.

2. Exclusion criteria:

  1. ≥75 years of age
  2. patients of pregnancy, nursing, possible gestation and desiring gestation;
  3. recent acute infection;
  4. previous history of systemic inflammatory diseases (like chronic hepatitis), malignant tumors and hematologic diseases;
  5. acute or chronic diseases of immune system;
  6. end-stage liver disease, kidney dysfunction (creatinine>2.0mg/dL, 176.8μmol/L) or accompanied nephrosis syndrome.
Criteria

Inclusion Criteria:

  1. confirmed CHD by coronary angiography
  2. IGT according to WHO standard (1999) as fasting blood-glucose of 6.1~7.0mmol/L and blood-glucose of 7.8~11.1mmol/L at 2 h after oral administration of 75g glucose
  3. accessible complete data of routine blood test and serum glucose before admission.-

Exclusion Criteria:

  1. ≥75 years of age
  2. patients of pregnancy, nursing, possible gestation and desiring gestation
  3. recent acute infection
  4. previous history of systemic inflammatory diseases (like chronic hepatitis), malignant tumors and hematologic diseases
  5. acute or chronic diseases of immune system
  6. end-stage liver disease, kidney dysfunction (creatinine>2.0mg/dL, 176.8μmol/L) or accompanied nephrosis syndrome -

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Responsible Party: Ke-Ye Liu, professor, Affiliated Hospital of Hebei University
ClinicalTrials.gov Identifier: NCT02149056     History of Changes
Other Study ID Numbers: 40170393-8
First Posted: May 29, 2014    Key Record Dates
Last Update Posted: May 29, 2014
Last Verified: May 2014

Keywords provided by Ke-Ye Liu, Affiliated Hospital of Hebei University:
Platelets/Lymphocytes Rate;Serological Index;

Additional relevant MeSH terms:
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Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Glucose Intolerance
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases