Clinical trial NCT02149056: Can Platelets/Lymphocytes Rate Be New Serological Index for Prognosis of Coronary Heart Disease Complicated With Impaired Glucose Tolerance: Basic Principles and Experimental Design
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Heart Disease Complicated With Impaired Glucose Tolerance
Keywords: Platelets/Lymphocytes Rate;Serological Index;
Lead sponsor: Affiliated Hospital of Hebei University
Sponsor class: OTHER
First posted: 2014-05-29
Enrollment: 447
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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 -

Primary outcomes:
measure: All cause mortality
timeFrame: One year
Secondary outcomes:
measure: correlations of PLR with MACE (including mortality, recurrent rate of infarction and reperfusion rate of target vessels)
timeFrame: one year
Other outcomes:
measure: recurrent infarction, re-perfusion rate of target vessel, intra-stand thrombogenesis, stroke and acute onset of heart failure
timeFrame: one year
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