Adverse outcome post acute coronary syndrome in diabetes
| ISRCTN | ISRCTN10805074 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10805074 |
| Secondary identifying numbers | Chinese National Science Foundation (Grant No 81300161) |
- Submission date
- 16/01/2017
- Registration date
- 20/01/2017
- Last edited
- 07/04/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Acute coronary syndrome (ACS) refers to a group of conditions due to decreased blood flow in the coronary arteries such that part of the heart muscle is unable to function properly or dies. It encompasses a range of sudden heart conditions, including heart attack and unstable angina attack (sudden chest pain). ACS mainly happens due to narrowing of the blood vessels which supply the heart due to a build-up of plaque (a fatty, sticky substance) on the walls of arteries. Treatment for ACS can include surgery to unblock the blood vessels to supply he heart and use of blood thinning medications. Patients who have type 2 diabetes (a condition where the sufferer is unable to control their blood sugar levels properly) are known to have a higher rate of complications than previously healthy patients. Previous studies have shown that that a protein called pregnancy-associated plasma protein-A (PAPP-A) is a potentially important biomarker (natural indicator) of dangerous plaque and inflammation (swelling) in patients with ACS and has been identified in heart plaque. Patients with type 2 diabetes appeared to have high levels of PAPP-A than healthy people of the same age. The aim of this study is to find out whether increased levels of PAPP-A are an indicator of future heart and blood vessel complications after ACS.
Who can participate?
All patients who have been hospitalised for ACS who have had their PAPP-A levels measured.
What does the study involve?
After being admitted to hospital for ACS, participants are treated by cardiologists (heart doctors) as usual, following standard ACS treatment guidelines. Participants attend follow up appointments after 6, 12 and 24 months, where they are interviewed to find out if they have had any heart and blood vessel complications, such as stroke or heart attacks. This is then confirmed by reviewing medical records.
What are the possible benefits and risks of participating?
There are no direct benefits or risks involved to those participating.
Where is the study run from?
The Beijing Friendship Hospital Cardiovascular Center, Capital Medical University (China)
When is the study starting and how long is it expected to run for?
June 2012 to December 2014
Who is funding the study?
Chinese National Science Foundation (China)
Who is the main contact?
Professor Xue-Qiao Zhao
xueqiao@uw.edu
Contact information
Scientific
University of Washington
Harborview Medical Center
325 9th Avenue
Seattle
98104
United States of America
 ORCID ID |
0000-0001-7713-6369 |
|---|---|
| Phone | +1 (0)206 744 8305 |
| xueqiao@uw.edu |
Study information
| Study design | Observational study. |
|---|---|
| Primary study design | Observational |
| Secondary study design | Longitudinal study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Pregnancy-associated plasma protein-A is a stronger predictor for adverse cardiovascular outcomes post-acute coronary syndrome in patients with type 2 diabetes mellitus |
| Study objectives | Pregnancy-associated plasma protein-A (PAPP-A) is predictive for future adverse cardiovascular outcomes in patients with type-2 diabetes (T2DM). |
| Ethics approval(s) | Beijing Friendship Hospital Institutional Review Board, 01/04/2012 |
| Health condition(s) or problem(s) studied | 1. Acute coronary syndrome 2. Type-2 diabetes mellitus (T2DM) |
| Intervention | All study participants are enrolled into the study during their ACS hospitalization. During hosptialisation, participants are treated using standard techniques. This may include percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG) and medication, as decided by treating cardiologists following ACS treatment guidelines. After hospital discharge, study participants are followed by their cardiologists for 24 months. After 6, 12 and 24 months, participants attend follow up visits at which the cardiovascular event rate is recorded. |
| Intervention type | Other |
| Primary outcome measure | 1. Cardiovascular death rate is assessed by medical record review and confirmed with death certificate at baseline, 6, 12 and 24 months of the 2 years of follow-up 2. Non-fatal MI rate is assessed by patient interview and confirmed by medical record review at baseline, 6, 12 and 24 months of the 2 years of follow-up 3. Non-fatal stroke rate is assessed by patient interview and confirmed by medical record review at baseline, 6, 12 and 24 months of the 2 years of follow-up |
| Secondary outcome measures | No secondary outcome measures. |
| Overall study start date | 15/06/2012 |
| Completion date | 30/12/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | All |
| Sex | Both |
| Target number of participants | 420 |
| Key inclusion criteria | 1. Confirmed acute coronary syndrome 2. Has PAPP-A measurements |
| Key exclusion criteria | 1. Aystemic inflammatory disease or cancer 2. Missing PAPP-A measurements |
| Date of first enrolment | 15/06/2012 |
| Date of final enrolment | 30/11/2012 |
Locations
Countries of recruitment
- China
Study participating centre
Xicheng District
Beijing
10050
China
Sponsor information
Government
83 Shuangqing Road
Haidian District
Beijing
100085
China
| Phone | +86 (0)106 231 7474 |
|---|---|
| webmaster@nsfc.gov.cn | |
"ROR" |
https://ror.org/01h0zpd94 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Chinese National Science Foundation, Natural Science Foundation of China, National Science Foundation of China, NNSF of China, NSF of China, 国家自然科学基金委员会, National Nature Science Foundation of China, Guójiā Zìrán Kēxué Jījīn Wěiyuánhuì, NSFC, NNSF, NNSFC
- Location
- China
Results and Publications
| Intention to publish date | 31/03/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Plans to public study results in the first quarter of 2017. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Moni Blazej Neradilek (moni@mwlight.com) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 05/04/2017 | Yes | No |
Editorial Notes
07/04/2017: Publication reference added.
