Study on connective tissue growth factor expressed in patients with ST-segment elevation myocardial infarction
| ISRCTN | ISRCTN20467848 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN20467848 |
| Secondary identifying numbers | N/A |
- Submission date
- 10/08/2015
- Registration date
- 31/08/2015
- Last edited
- 20/08/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Connective tissue growth factor (CTGF) is a protein which helps to make connective tissue, which connects, supports, binds, or separates other tissues or organs in the body. It has been found that CTGF can contribute to the thickening and stiffening of the heart valves. This can lead to conditions such as unstable angina (UA), a type of chest pain caused by poor blood flow to the heart which can lead to a heart attack, and ST-segment elevation myocardial infarction (STEMI), which is a type of heart attack. When a person has a heart attack, an enzyme called creatine kinase MB (CK-MB) is released into the blood by the injured heart muscle.
The aim of this study is to find out whether there is a link between the amount of CTGF in the body and the size of a heart attack. The study also aims to find out if the levels of CTGF relate to the levels of the CK-MB in STEMI patients.
Who can participate?
Adults suffering from sudden STEMI or UA.
What does the study involve?
Participants with UA have a blood test when they are admitted to hospital to test the level of CTGF in their blood. For participants who are suffering from STEMI, a sample of blood is taken 24 hours, 2 days, 7 days and 14 days after the heart attack itself. Blood is also taken every two hours in order to test for CK-MB, and to work out the when the levels in the blood are at their highest.
What are the possible benefits and risks of participating?
There are no notable benefits or risks for the participants.
Where is the study run from?
The Second Affiliated Hospital of Xuzhou Medical College (China)
When is the study starting and how long is it expected to run for?
July 2013 to March 2015
Who is funding the study?
The Second Affiliated Hospital of Xuzhou Medical College (China)
Who is the main contact?
Dr Yong Li
liyongmyzone@126.com
Contact information
Scientific
Chest Pain Center
The second affiliated hospital of Xuzhou Medical College
32 Meijian Road
Quanshan District
Xuzhou
221006
China
 ORCID ID |
0000-0003-4583-8643 |
|---|
Study information
| Study design | Observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Connective Tissue Growth Factor was significantly expressed in ST-segment elevation Myocardial Infarction patients |
| Study acronym | CTGFMI |
| Study objectives | To determine whether connective tissue growth factor assessment is a good index of the infarction size. |
| Ethics approval(s) | The Second Affiliated Hospital of Xuzhou Medical College Ethics Committee, 25/06/2013, ref: SMC1306-25. |
| Health condition(s) or problem(s) studied | 1. ST-segment elevation myocardial infarction 2. Angina |
| Intervention | All the patients received conventional intensive medical treatment and elective PCI after hospitalization. The door-to-balloon time was （278.3±43.2）hours for these 94 patients from chest pain to infarction-related artery .Patients with myocardial infarction were extracted 5ml of venous blood to detect CTGF 24h, 2 days, 7 days, 14 days after disease onset respectively. Patients with UA were extracted 5ml of venous blood to detect CTGF at the time of hospitalization. Patients with STEMI were extracted 5ml of venous blood every two hours to detect CKMB and to obtain CKMB enzyme peak value. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | The serum level of connective tissue growth factor (CTGF) and Creatine kinase-MB (CKMB) maximal value. |
| Secondary outcome measures | 1. Ventricular ejection fraction. 2. Mortality Rate. |
| Overall study start date | 03/07/2013 |
| Completion date | 15/04/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 194 |
| Key inclusion criteria | Suffering from one of the following: 1. Acute ST elevation myocardial infarction without direct PCI 2. Thrombolytic indications 3. Unstable angina |
| Key exclusion criteria | 1. Previous severe valvular disease 2. Cardiomyopathy 3. Severe chronic heart failure 4. Persistent atrial fibrillation. |
| Date of first enrolment | 03/07/2013 |
| Date of final enrolment | 10/03/2015 |
Locations
Countries of recruitment
- China
Study participating centre
Quanshan District
Xuzhou
221006
China
Sponsor information
Hospital/treatment centre
Chest Pain Center
32 Meijian Road
Quanshan District
Xuzhou
221006
China
"ROR" |
https://ror.org/04yrcjm56 |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 15/09/2015 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planning to publish results of trial soon in a peer reviewed journal. |
| IPD sharing plan |
