Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Prof Xue-Qiao Zhao
ORCID ID
http://orcid.org/0000-0001-7713-6369
Contact details
University of Washington
Harborview Medical Center
325 9th Avenue
Seattle
98104
United States of America
+1 (0)206 744 8305
xueqiao@uw.edu
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Chinese National Science Foundation (Grant No 81300161)
Study information
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
Acronym
Study hypothesis
Pregnancy-associated plasma protein-A (PAPP-A) is predictive for future adverse cardiovascular outcomes in patients with type-2 diabetes (T2DM).
Ethics approval
Beijing Friendship Hospital Institutional Review Board, 01/04/2012
Study design
Observational study.
Primary study design
Observational
Secondary study design
Longitudinal study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
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
Phase
Drug names
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 trial start date
15/06/2012
Overall trial end date
30/12/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Confirmed acute coronary syndrome
2. Has PAPP-A measurements
Participant type
Patient
Age group
All
Gender
Both
Target number of participants
420
Participant exclusion criteria
1. Aystemic inflammatory disease or cancer
2. Missing PAPP-A measurements
Recruitment start date
15/06/2012
Recruitment end date
30/11/2012
Locations
Countries of recruitment
China
Trial participating centre
The Beijing Friendship Hospital Cardiovascular Center, Capital Medical University
95th Yongan Road
Xicheng District
Beijing
10050
China
Sponsor information
Organisation
Chinese National Science Foundation
Sponsor details
83 Shuangqing Road
Haidian District
Beijing
100085
China
+86 (0)106 231 7474
webmaster@nsfc.gov.cn
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
National Natural Science Foundation of China
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, The National Natural Science Foundation of China, NSFC, NNSF, NNSFC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
China
Results and Publications
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)
Intention to publish date
31/03/2017
Participant level data
Available on request
Basic results (scientific)
Publication list
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28381225