Myocardial InfarctionPhase 4NCT00863629
Tight Glycemic Control Increases Cardiac Stem Cells During Acute Myocardial Infarction
A Phase 4 study testing Insulin in people with Myocardial Infarction and Oxidative Stress, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
Trial summary
Objectives. The investigators analysed the effects of tight glycemic control in regenerative potential of the myocardium during acute myocardial infarction (AMI). Background. A strict glycemic control after AMI improves the cardiac outcome. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Myocardial Infarction, Oxidative Stress, Glycemic Control
- What is being tested?
- Insulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2001to Jan 2009
- Phase
- Phase 4
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- evidence of AMI within the last 8 h (troponin-I >2.50 µg/l together with either typical symptoms of angina or electrographic criteria of ST-segment modification)
- first uncomplicated AMI
- the need for CABG
Who cannot join
- previous AMI
- inflammatory disorders
- malignancy
- renal diseases infections
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tight Glycemic Control Increases Cardiac Stem Cells and Reduces Heart Remodeling During Acute Myocardial Infarction in Hyperglycemic Patients
Objectives. The investigators analysed the effects of tight glycemic control in regenerative potential of the myocardium during acute myocardial infarction (AMI).
Background. A strict glycemic control after AMI improves the cardiac outcome. The role of tight glycemic control in regenerative potential of the myocardium during acute myocardial ischemia are still largely unknown.
Methods. Sixty-five patients with first AMI undergoing coronary bypass surgery were studied: 25 normoglycemic patients served as control group; hyperglycemic patients (glucose >140 mg/dl) were randomized to intensive glycemic control (IGC, n=20; glucose goal 80-140 mg/dl) or conventional glycemic control (CGC, n=20; glucose goal180-200 mg/dl) for almost 3 days before surgery, using insulin infusion followed by subcutaneous insulin treatment. Echocardiographic parameters were investigated at admission and after treatment period. During surgery, oxidative stress (nitrotyrosine, O2- production), apoptosis (Caspase-3) and cardiac stem cells (CSCs) (c-kit, MDR1 and Sca-1 positive cells) were analysed in biopsy specimens taken from the peri-infarcted area.
Read the detailed description
The study design was structured on the basis of protocol Yale . Upon emergency wards admission, hyperglycemic patients were randomly assigned to IGC or CGC. In patients with STEMI the insulin infusion was started after thrombolysis. In the CGC group, continuous insulin infusion of 50 IU Actrapid HM (Novo Nordisk) in 50 ml NaCl (0.9% using a Perfusor-FM pump) was started only when blood glucose levels exceeded 200 mg/dl and adjusted to keep blood glucose between 180 and 200 mg/dl. When blood glucose fell <180 mg/dl, insulin infusion was slowed down and eventually stopped. In the IGC group, insulin infusion was started when blood glucose levels exceeded 140 mg/dl and adjusted to maintain glycemia at 80-140 mg/dl. During insulin infusion, oral feeding was stopped and parenteral nutrition (13±5 Kcal/kg-1/day-1) was started. After the start of insulin infusion protocol a glycemic control was provided every hour in order to obtain three consecutive values that were within the goal range. Capillary glucose levels were measured by fingerstick testing. Additionally, plasma glucose levels were checked every two hours in both CGC and IGT patients throughout the study period. Both measurements were no statistically different . The infusion lasted until stable glycemic goal (ICG group: 80-140 mg/dl; CGC group: 180-200 mg/dl) at least for 24 h. After glycemic goal were maintained for 24 h, a parenteral nutrition was stopped and feeding was started according to European guidelines (10). Subcutaneous insulin was initiated at the cessation of the infusion. Insulin was given as short-acting insulin before meals and intermediate long-acting insulin in the evening, in both group. In IGC group, the treatment goal was a fasting blood glucose level of 90-140 mg/dl and a non-fasting (two hours after meal) level of <180 mg/dl (4). In CGC group, the treatment goal was fasting blood glucose and postprandial levels of <200 mg/dl. With regard to the full medical therapy, the protocol stated that the use of concomitant treatment should be as uniform as possible and according to evidence-based international guidelines for AMI.
Echocardiographic assessment. Patients enrolled in the study underwent two-dimensional echocardiography at admission before starting full medical therapy as well as after achieved glycemic control goal for almost 3 days, before surgery. The study was performed using a standardized protocol and phased-array echocardiographs with M-mode, two-dimensional, and pulsed, continuous-wave, and color flow Doppler capabilities. The ejection fraction was calculated from area measurements using the area-length method applied to the average apical area. The left ventricular internal dimension and interventricular septal were measured at the end diastole and end systole, and the wall motion score index was calculated according to American Society of Echocardiography recommendations. Isovolumetric relaxation time (IRT) was the time interval from cessation of left ventricular outflow to onset of mitral inflow, the ejection time (ET) was the time interval between the onset and the cessation of left ventricular outflow, and the mitral early diastolic flow deceleration time was the time interval between the peak early diastolic flow velocity and the end of the early diastolic flow. The total systolic time interval was measured from the cessation of one mitral flow to the beginning of the following mitral inflow. Isovolumetric contracting time (ICT) was calculated by subtracting ET and IRT from the total systolic time interval. The ratio of velocity time intervals (vti) of mitral early (E) and late (A) diastolic flows (Evti/Avti) was calculated. The myocardial performance index (MPI) was calculated as (IRT+ICT)/ET.
Biopsy of myocardium. All patients were undergone to CABG after maintained glucose goal for almost 3 days. After induction of anaesthesia and median sternotomy, the heart of each patient was examined, and 3-mm partial-thickness biopsy specimens were taken from the peri-infarcted area. The infarcted zone was identified as a yellow area surrounded by a purple band of granulation tissue or as gray area with fine yellow lines at its periphery. The peri-infarct zone was identified as a zone immediately adjacent the zone with the anatomical characteristics of myocardial infarct. Moreover, the transesophageal echocardiogram (TEE) was performer to evaluate peri-infarct zone All biopsies were performed before CABG, during ventilation with a fraction of inspired oxygen of 40% and peripheral oxygen saturations of >95%.
Analysis of specimens. Half of each biopsy specimen was fixed in formalin, sectioned to a thickness of 5 µm, mounted on slides, and stained with hematoxylin and eosin. The mounted specimens were then examined for evidence of ischemia or kept for immunohistechemistry. The other half of the specimen was frozen in liquid nitrogen for Western Blotting analysis.
- Conditions
- Myocardial Infarction, Oxidative Stress, Glycemic Control
- Being tested
- Insulin
- Keywords
- myocardial infarction, oxidative stress, stem cells, glycemic control
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InsulinDrug
In the CGC group, continuous insulin infusion was started only when blood glucose levels exceeded 200 mg/dl and adjusted to keep blood glucose between 180 and 200 mg/dl. When blood glucose fell <180 mg/dl, insulin infusion was tapered slowed down and eventually stopped. In the IGC group, insulin infusion was started when blood glucose levels exceeded 140 mg/dl and adjusted to maintain glycemia at 80-140 mg/dl. After the start of insulin infusion protocol a glycemic control was provided every hour in order to obtain three consecutive values that were within the goal range. Plasma glucose levels were checked every two hours in both CGC and IGT patients throughout the study period. The infusion lasted until stable glycemic goal (ICG group: 80-140 mg/dl; CGC group: 180-200 mg/dl) at least for 24 h. Subcutaneous insulin was initiated at the cessation of the infusion. Insulin was given as short-acting insulin before meals and intermediate long-acting insulin in the evening, in both group.
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | 25 normoglycemic patients as control group |
| 2 | Active comparator | 20 hyperglycemic patients (glucose >140 mg/dl) randomized to conventional glycemic control by insulin (CGC group; glucose goal 180-200 mg/dl) Receives: Drug: Insulin |
| 3 | Experimental | 20 hyperglycemic patients (glucose >140 mg/dl) were randomized to intensive glycemic control by insunin (IGC group; glucose goal 80-140 mg/dl) Receives: Drug: Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiac stem cells during acute myocardial infarction
Measured: 3 days of treatment
Secondary outcomes (1)
heart remodeling during acute myocardial infarction
Measured: 3 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2009 (estimated)
- Study startJan 2001
- Primary completionJun 2008
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Investigators
- Raffaele Marfella, MD, PhD, Principal investigator, University of Campania Luigi Vanvitelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00863629
- Sponsor's protocol ID
- I-4546789
- Status last verified
- Mar 2009
- First submitted
- 16 Mar 2009
- Last updated
- 18 Mar 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kunz GA, Liang G, Cuculi F, Gregg D, Vata KC, Shaw LK, Goldschmidt-Clermont PJ, Dong C, Taylor DA, Peterson ED. Circulating endothelial progenitor cells predict coronary artery disease severity. Am Heart J. 2006 Jul;152(1):190-5. doi: 10.1016/j.ahj.2006.02.001.
PubMed 16824855Assmus B, Walter DH, Lehmann R, Honold J, Martin H, Dimmeler S, Zeiher AM, Schachinger V. Intracoronary infusion of progenitor cells is not associated with aggravated restenosis development or atherosclerotic disease progression in patients with acute myocardial infarction. Eur Heart J. 2006 Dec;27(24):2989-95. doi: 10.1093/eurheartj/ehl235. Epub 2006 Oct 19.
PubMed 17053006Pal R. Embryonic stem (ES) cell-derived cardiomyocytes: a good candidate for cell therapy applications. Cell Biol Int. 2009 Mar;33(3):325-36. doi: 10.1016/j.cellbi.2008.12.001. Epub 2008 Dec 14.
PubMed 19121644Marfella R, Sasso FC, Cacciapuoti F, Portoghese M, Rizzo MR, Siniscalchi M, Carbonara O, Ferraraccio F, Torella M, Petrella A, Balestrieri ML, Stiuso P, Nappi G, Paolisso G. Tight glycemic control may increase regenerative potential of myocardium during acute infarction. J Clin Endocrinol Metab. 2012 Mar;97(3):933-42. doi: 10.1210/jc.2011-2037. Epub 2011 Dec 14.
PubMed 22170713
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tight Glycemic Control Increases Cardiac Stem Cells and Reduces Heart Remodeling During Acute Myocardial Infarction in Hyperglycemic Patients
- ClinicalTrials.gov ID
- NCT00863629
- Acronym / sponsor ID
- I-4546789
- Conditions
- Myocardial Infarction, Oxidative Stress, Glycemic Control
- Keywords
- myocardial infarction, oxidative stress, stem cells, glycemic control
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- Jan 2001
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 18 Mar 2009 (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.
Objectives. The investigators analysed the effects of tight glycemic control in regenerative potential of the myocardium during acute myocardial infarction (AMI).
Background. A strict glycemic control after AMI improves the cardiac outcome. The role of tight glycemic control in regenerative potential of the myocardium during acute myocardial ischemia are still largely unknown.
Methods. Sixty-five patients with first AMI undergoing coronary bypass surgery were studied: 25 normoglycemic patients served as control group; hyperglycemic patients (glucose >140 mg/dl) were randomized to intensive glycemic control (IGC, n=20; glucose goal 80-140 mg/dl) or conventional glycemic control (CGC, n=20; glucose goal180-200 mg/dl) for almost 3 days before surgery, using insulin infusion followed by subcutaneous insulin treatment. Echocardiographic parameters were investigated at admission and after treatment period. During surgery, oxidative stress (nitrotyrosine, O2- production), apoptosis (Caspase-3) and cardiac stem cells (CSCs) (c-kit, MDR1 and Sca-1 positive cells) were analysed in biopsy specimens taken from the peri-infarcted area.
Detailed description
The study design was structured on the basis of protocol Yale . Upon emergency wards admission, hyperglycemic patients were randomly assigned to IGC or CGC. In patients with STEMI the insulin infusion was started after thrombolysis. In the CGC group, continuous insulin infusion of 50 IU Actrapid HM (Novo Nordisk) in 50 ml NaCl (0.9% using a Perfusor-FM pump) was started only when blood glucose levels exceeded 200 mg/dl and adjusted to keep blood glucose between 180 and 200 mg/dl. When blood glucose fell <180 mg/dl, insulin infusion was slowed down and eventually stopped. In the IGC group, insulin infusion was started when blood glucose levels exceeded 140 mg/dl and adjusted to maintain glycemia at 80-140 mg/dl. During insulin infusion, oral feeding was stopped and parenteral nutrition (13±5 Kcal/kg-1/day-1) was started. After the start of insulin infusion protocol a glycemic control was provided every hour in order to obtain three consecutive values that were within the goal range. Capillary glucose levels were measured by fingerstick testing. Additionally, plasma glucose levels were checked every two hours in both CGC and IGT patients throughout the study period. Both measurements were no statistically different . The infusion lasted until stable glycemic goal (ICG group: 80-140 mg/dl; CGC group: 180-200 mg/dl) at least for 24 h. After glycemic goal were maintained for 24 h, a parenteral nutrition was stopped and feeding was started according to European guidelines (10). Subcutaneous insulin was initiated at the cessation of the infusion. Insulin was given as short-acting insulin before meals and intermediate long-acting insulin in the evening, in both group. In IGC group, the treatment goal was a fasting blood glucose level of 90-140 mg/dl and a non-fasting (two hours after meal) level of <180 mg/dl (4). In CGC group, the treatment goal was fasting blood glucose and postprandial levels of <200 mg/dl. With regard to the full medical therapy, the protocol stated that the use of concomitant treatment should be as uniform as possible and according to evidence-based international guidelines for AMI.
Echocardiographic assessment. Patients enrolled in the study underwent two-dimensional echocardiography at admission before starting full medical therapy as well as after achieved glycemic control goal for almost 3 days, before surgery. The study was performed using a standardized protocol and phased-array echocardiographs with M-mode, two-dimensional, and pulsed, continuous-wave, and color flow Doppler capabilities. The ejection fraction was calculated from area measurements using the area-length method applied to the average apical area. The left ventricular internal dimension and interventricular septal were measured at the end diastole and end systole, and the wall motion score index was calculated according to American Society of Echocardiography recommendations. Isovolumetric relaxation time (IRT) was the time interval from cessation of left ventricular outflow to onset of mitral inflow, the ejection time (ET) was the time interval between the onset and the cessation of left ventricular outflow, and the mitral early diastolic flow deceleration time was the time interval between the peak early diastolic flow velocity and the end of the early diastolic flow. The total systolic time interval was measured from the cessation of one mitral flow to the beginning of the following mitral inflow. Isovolumetric contracting time (ICT) was calculated by subtracting ET and IRT from the total systolic time interval. The ratio of velocity time intervals (vti) of mitral early (E) and late (A) diastolic flows (Evti/Avti) was calculated. The myocardial performance index (MPI) was calculated as (IRT+ICT)/ET.
Biopsy of myocardium. All patients were undergone to CABG after maintained glucose goal for almost 3 days. After induction of anaesthesia and median sternotomy, the heart of each patient was examined, and 3-mm partial-thickness biopsy specimens were taken from the peri-infarcted area. The infarcted zone was identified as a yellow area surrounded by a purple band of granulation tissue or as gray area with fine yellow lines at its periphery. The peri-infarct zone was identified as a zone immediately adjacent the zone with the anatomical characteristics of myocardial infarct. Moreover, the transesophageal echocardiogram (TEE) was performer to evaluate peri-infarct zone All biopsies were performed before CABG, during ventilation with a fraction of inspired oxygen of 40% and peripheral oxygen saturations of >95%.
Analysis of specimens. Half of each biopsy specimen was fixed in formalin, sectioned to a thickness of 5 µm, mounted on slides, and stained with hematoxylin and eosin. The mounted specimens were then examined for evidence of ischemia or kept for immunohistechemistry. The other half of the specimen was frozen in liquid nitrogen for Western Blotting analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –25 normoglycemic patients as control group |
| 2 | Active comparator | Drug: Insulin20 hyperglycemic patients (glucose >140 mg/dl) randomized to conventional glycemic control by insulin (CGC group; glucose goal 180-200 mg/dl) |
| 3 | Experimental | Drug: Insulin20 hyperglycemic patients (glucose >140 mg/dl) were randomized to intensive glycemic control by insunin (IGC group; glucose goal 80-140 mg/dl) |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- evidence of AMI within the last 8 h (troponin-I >2.50 µg/l together with either typical symptoms of angina or electrographic criteria of ST-segment modification)
- first uncomplicated AMI
- the need for CABG
Key exclusion criteria (4 listed)
- previous AMI
- inflammatory disorders
- malignancy
- renal diseases infections
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 |
|---|---|---|
| InsulinIn the CGC group, continuous insulin infusion was started only when blood glucose levels exceeded 200 mg/dl and adjusted to keep blood glucose between 180 and 200 mg/dl. When blood glucose fell <180 mg/dl, insulin infusion was tapered slowed down and eventually stopped. In the IGC group, insulin infusion was started when blood glucose levels exceeded 140 mg/dl and adjusted to maintain glycemia at 80-140 mg/dl. After the start of insulin infusion protocol a glycemic control was provided every hour in order to obtain three consecutive values that were within the goal range. Plasma glucose levels were checked every two hours in both CGC and IGT patients throughout the study period. The infusion lasted until stable glycemic goal (ICG group: 80-140 mg/dl; CGC group: 180-200 mg/dl) at least for 24 h. Subcutaneous insulin was initiated at the cessation of the infusion. Insulin was given as short-acting insulin before meals and intermediate long-acting insulin in the evening, in both group. | Drug | 2, 3 |
Primary outcome
cardiac stem cells during acute myocardial infarction
Time frame: 3 days of treatment
1 secondary outcome
heart remodeling during acute myocardial infarction
Time frame: 3 days of treatment
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 18 Mar 2009.
- Background: PubMed 16824855Kunz GA, Liang G, Cuculi F, Gregg D, Vata KC, Shaw LK, Goldschmidt-Clermont PJ, Dong C, Taylor DA, Peterson ED. Circulating endothelial progenitor cells predict coronary artery disease severity. Am Heart J. 2006 Jul;152(1):190-5. doi: 10.1016/j.ahj.2006.02.001.
- Background: PubMed 17053006Assmus B, Walter DH, Lehmann R, Honold J, Martin H, Dimmeler S, Zeiher AM, Schachinger V. Intracoronary infusion of progenitor cells is not associated with aggravated restenosis development or atherosclerotic disease progression in patients with acute myocardial infarction. Eur Heart J. 2006 Dec;27(24):2989-95. doi: 10.1093/eurheartj/ehl235. Epub 2006 Oct 19.
- Background: PubMed 19121644Pal R. Embryonic stem (ES) cell-derived cardiomyocytes: a good candidate for cell therapy applications. Cell Biol Int. 2009 Mar;33(3):325-36. doi: 10.1016/j.cellbi.2008.12.001. Epub 2008 Dec 14.
- Derived from this study: PubMed 22170713Marfella R, Sasso FC, Cacciapuoti F, Portoghese M, Rizzo MR, Siniscalchi M, Carbonara O, Ferraraccio F, Torella M, Petrella A, Balestrieri ML, Stiuso P, Nappi G, Paolisso G. Tight glycemic control may increase regenerative potential of myocardium during acute infarction. J Clin Endocrinol Metab. 2012 Mar;97(3):933-42. doi: 10.1210/jc.2011-2037. Epub 2011 Dec 14.
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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.
Raffaele Marfella, MD, PhD principal investigator
University of Campania Luigi Vanvitelli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Insulin in people with Myocardial Infarction and Oxidative Stress, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
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 4 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 18 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
cardiac stem cells during acute myocardial infarction (time frame: 3 days of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00863629, which also lists 4 linked publications.
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 18 Mar 2009.