Coronary Heart Disease Complicated With Impaired Glucose Tolerance Clinical Trial
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
| Verified date | May 2014 |
| Source | Affiliated Hospital of Hebei University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | China: Ethics Committee |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 447 |
| Est. completion date | August 2013 |
| Est. primary completion date | August 2013 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 30 Years to 75 Years |
| Eligibility |
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 - |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Affiliated Hospital of Hebei University |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | recurrent infarction, re-perfusion rate of target vessel, intra-stand thrombogenesis, stroke and acute onset of heart failure | one year | Yes | |
| Primary | All cause mortality | One year | Yes | |
| Secondary | correlations of PLR with MACE (including mortality, recurrent rate of infarction and reperfusion rate of target vessels) | one year | Yes |