ISRCTN - ISRCTN10805074: Adverse outcome post acute coronary syndrome in diabetes

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