Management of hyperglycaemia and platelet activity in patients with acute coronary syndrome
| ISRCTN | ISRCTN35708451 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN35708451 |
| Secondary identifying numbers | N/A |
- Submission date
- 11/10/2007
- Registration date
- 11/01/2008
- Last edited
- 02/10/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Antonio Fernandez-Ortiz
Scientific
Scientific
c/o Prof Martin Lagos, sn
Hospital Clínico San Carlos
Unidad Coronaria
Madrid
28040
Spain
Study information
| Study design | Open single-centre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet. |
| Scientific title | |
| Study acronym | CHIPS |
| Study objectives | A tight glucose control with intravenous insulin in patients suffering from acute coronary syndrome (ACS) would decrease their platelet reactivity compared to subcutaneous insulin. On 26/06/2008 the sources of funding field was changed from 'Grant application submitted to the Spanish Foundation for Investigation in Science (FIS). Decision pending as of 11/01/2008' to 'Foundation for Development and Cardiovascular Research (Spain)'. On 10/08/2009 the following changes were made to the trial record: 1. The target number of participants was changed from 200 to 115. 2. The sources of funding was changed from 'Foundation for Development and Cardiovascular Research (Spain)' to 'Foundation for Cardiovascular Research (Fundación Investigación Cardiovascular [FIC]) (Spain)'. |
| Ethics approval(s) | Local Ethics Committee of the Hospital Clinico San Carlos (Coordinación de ensayos clinicos del Hospital Clinico San Carlos), 07/03/2007, amendments approved 12/12/2007, ref: 07/062 |
| Health condition(s) or problem(s) studied | Acute coronary syndrome |
| Intervention | Patients are randomised to one of two protocols of glycaemic control. Intervention group (therapy A): intensive treatment. The aim was to obtain a glycaemia of 80 to 120 mg/dl (4.44 to 6.66 mmol/l). Infusion of insulin is started and hourly controls of the rate of infusion was carried out according to a chart elaborated by the Diabetes Unit of our centre. After 24 hours of insulin infusion, a nocturnal dose of ultra-slow insulin was calculated, together with fast subcutaneous insulin before meals. Control group (therapy B): standard treatment. The aim was to obtain a glycaemia of less than 180 mg/dl (9.99 mmol/l). The participants were treated with fast subcutaneous insulin before meals, according to a corrective chart, together with slow insulin twice a day (bid). In patients diagnosed with diabetes, the dose of slow insulin was calculated from their previous treatment or according to the weight (0.1 unit per kilogram every 12 h) As of 10/08/2009, recruitment has ended for this trial. The last patient was recruited on 29/07/2009. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Insulin |
| Primary outcome measure | 1. Effects of treatment on platelet reactivity. Platelet reactivity at baseline, 24 and 48 hours will be assessed by the following: 1.1. Platelet activation: flow cytometry; analysis of platelet P-selectin and GPIIb/IIIa, basal and activated with ADP (1 and 5 µM) and thrombin receptor activating peptide (TRAP) (1 and 5 µM) 1.2. Intracellular expression of vasodilator-stimulated phosphoprotein (VASP) 1.3. Soluble sCD40L 1.4. Platelet aggregation 2. Metabolic study: free fatty acids, leptin, adiponectin, and ßOH-butirate. They will be assessed at baseline, 24 and 48 hours, 3, 6, 9 and 12 months of follow-up 3. Influence of platelet polymorphisms on treatment effects. Genetic polymorphisms will be assessed by polymerase chain reaction (PCR) for P-selectin receptor, platelet ADP receptor and phospholipase A2 receptor (PLA2) receptor of GPIIb/IIIa |
| Secondary outcome measures | Current secondary outcome measures as of 10/08/2009: Association between the parameters above and cardiovascular major events during follow-up, between different levels of glycaemia, different evolution of diabetes mellitus (quantified by HbA1c, ages of evolution, type of treatment) Previous secondary outcome measures: Clinical outcome: association between the parameters above and cardiovascular major events during follow-up. Cardiovascular major events (death, reinfarction, angina, revascularisation, ictus, cardiogenic shock, pulmonary oedema) during follow-up will be recorded. |
| Overall study start date | 26/03/2007 |
| Completion date | 26/03/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 115 (added 10/08/2009) |
| Key inclusion criteria | Consecutive patients admitted to the Coronary Care Unit with ACS and hyperglycaemia will be enrolled if they meet the following criteria: 1. Chest pain in the 24 hours previous to their inclusion 2. Older than 18 years 3. Written informed consent 4. Participant must have one of the following: 4.1. ST segment elevation of at least 0.1 mV in two or more adjacent leads 4.2. New onset left bundle branch block 4.3. ST segment depression of at least 0.1 mV in two or more adjacent leads 4.4. Markers of myocardial necrosis (cardiac troponin I above normal levels) 5. Participants must have one of the following: 5.1. Known diabetes and glycaemia greater than 120 mg/dl (6.66 mmol/l) on admission 5.2. No diagnosis of diabetes and glycaemia greater than 160 mg/dl (8.88 mmol/l) on admission 5.3. No diagnosis of diabetes and glycaemia between 120 to 160 mg/dl at admission, and greater than 120 mg/dl one hour later |
| Key exclusion criteria | 1. Women of childbearing age 2. Inclusion in another clinical trial 3. Life expectancy of less than 1 year 4. High probability of loss on follow-up 5. Unclear origin of chest pain 6. Patients with scheduled percutaneous coronary interventions with complications during the procedure and are admitted to the Coronary Unit, but without chest pain in the last 24 hours 7. Patients on mechanical ventilation 8. Ethical barriers (e.g., patients who are not fluent in Spanish, relatives of investigators) 9. Glycaemia greater than 400 mg% (22.20 mmol/l) on admission |
| Date of first enrolment | 26/03/2007 |
| Date of final enrolment | 26/03/2009 |
Locations
Countries of recruitment
- Spain
Study participating centre
c/o Prof Martin Lagos, sn
Madrid
28040
Spain
28040
Spain
Sponsor information
Hospital Clínico San Carlos, Instituto Cardiovascular (Spain)
Hospital/treatment centre
Hospital/treatment centre
c/o Prof Martin Lagos, sn
Cardiology Department
Madrid
28040
Spain
| Website | http://www.hcsc.es |
|---|---|
"ROR" |
https://ror.org/04d0ybj29 |
Funders
Funder type
Research organisation
Foundation for Cardiovascular Research (Fundación Investigación Cardiovascular [FIC]) (Spain)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2011 | Yes | No |
