Coronary Heart Disease Complicated With Impaired Glucose ToleranceNCT02149056
Can Platelets/Lymphocytes Rate Be New Serological Index for Prognosis of Coronary Heart Disease Complicated With Impaired Glucose Tolerance: Basic Principles and Experimental Design
An observational study of Coronary Heart Disease Complicated With Impaired Glucose Tolerance, run by Affiliated Hospital of Hebei University.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Heart Disease Complicated With Impaired Glucose Tolerance
- What is being tested?
- observation and Impaired Glucose Tolerance
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 447 participants
- Where
- No sites listed yet
- Study dates
- Aug 2013to Aug 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- confirmed CHD by coronary angiography
- 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
- accessible complete data of routine blood test and serum glucose before admission.-
Who cannot join
- ≥75 years of age
- patients of pregnancy, nursing, possible gestation and desiring gestation
- recent acute infection
- previous history of systemic inflammatory diseases (like chronic hepatitis), malignant tumors and hematologic diseases
- acute or chronic diseases of immune system
- end-stage liver disease, kidney dysfunction (creatinine>2.0mg/dL, 176.8μmol/L) or accompanied nephrosis syndrome -
About this study
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.
- Being tested
- observation, Impaired Glucose Tolerance
- Keywords
- Platelets/Lymphocytes Rate;Serological Index;
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationBehavioural
Impaired Glucose ToleranceOther
Impaired Glucose Tolerance
| Study group | Role | What they receive |
|---|---|---|
| Impaired Glucose Tolerance | Not described Receives: Behavioral: observation; Other: Impaired Glucose Tolerance |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality
Measured: One year
Secondary outcomes (1)
correlations of PLR with MACE (including mortality, recurrent rate of infarction and reperfusion rate of target vessels)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2014 (estimated)
- Study startAug 2013
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart Disease Complicated With Impaired Glucose ToleranceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 447 participants (actual)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Hebei University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ke-Ye Liu, Affiliated Hospital of Hebei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02149056
- Sponsor's protocol ID
- 40170393-8
- Status last verified
- May 2014
- First submitted
- 26 May 2014
- Last updated
- 29 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02149056
- Acronym / sponsor ID
- 40170393-8
- Keywords
- Platelets/Lymphocytes Rate;Serological Index;
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 447 participants (actual)
- Lead sponsor
- Affiliated Hospital of Hebei UniversityUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 29 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Impaired Glucose Tolerance | – | Behavioral: observation, Other: Impaired Glucose Tolerance |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- confirmed CHD by coronary angiography
- 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
- accessible complete data of routine blood test and serum glucose before admission.-
Key exclusion criteria (6 listed)
- ≥75 years of age
- patients of pregnancy, nursing, possible gestation and desiring gestation
- recent acute infection
- previous history of systemic inflammatory diseases (like chronic hepatitis), malignant tumors and hematologic diseases
- acute or chronic diseases of immune system
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observation | Behavioural | Impaired Glucose Tolerance |
| Impaired Glucose ToleranceImpaired Glucose Tolerance | Other | Impaired Glucose Tolerance |
Primary outcome
All cause mortality
Time frame: One year
1 secondary outcome
correlations of PLR with MACE (including mortality, recurrent rate of infarction and reperfusion rate of target vessels)
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2014.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Heart Disease Complicated With Impaired Glucose Tolerance, run by Affiliated Hospital of Hebei University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause mortality (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2014.