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Trial registered on ANZCTR


Registration number
ACTRN12617000648325
Ethics application status
Approved
Date submitted
2/05/2017
Date registered
4/05/2017
Date last updated
4/05/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does high-sensitivity C-reactive protein (hsCRP) predict coronary microvessel function in patients with coronary artery disease?
Scientific title
Does high-sensitivity C-reactive protein (hsCRP) predict coronary microvascular dysfunction in patients with coronary artery disease?
Secondary ID [1] 291839 0
None
Universal Trial Number (UTN)
U1111-1196-2246
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary artery disease 303085 0
Condition category
Condition code
Cardiovascular 302543 302543 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Coronary microvessel function is evaluated in patients who undergo percutaneous coronary stenting. Index of microvascular resistance (IMR) represents microvascular function and is derived from measurements taken using a pressure-temperature sensor-tipped wire. These measurements are taken before and after coronary stents are deployed. The procedure is performed by the treating interventional cardiologist. Blood samples are collected to measure the inflammatory markers. Patient demographics and procedural characteristics data are collected.
Intervention code [1] 297953 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 301967 0
To evaluate the association between serum hsCRP level and coronary microvessel function. Index of microvascular resistance (IMR) which represents coronary microvessel function is assessed using a pressure-temperature sensor-tipped wire during coronary intervention.
Timepoint [1] 301967 0
Serum samples are collected from the coronary catheter at the start of the coronary intervention procedure. Baseline IMR is measured prior to coronary artery stenting. IMR measurement is repeated after coronary stenting.
Secondary outcome [1] 334404 0
Myocardial injury as assessed by peak serum troponin and creatine kinase (CK) levels. Troponin and creatine kinase (CK) were sequentially measured every 6 h up to a maximum of 24 h following coronary intervention.
Timepoint [1] 334404 0
24 hours after coronary intervention
Secondary outcome [2] 334433 0
To assess the impact of different antiplatelet medications (clopidogrel vs. ticagrelor vs. prasugrel) on microvascular function. These antiplatelet medications are routinely given to cardiac patients prior to coronary intervention. The choice of antiplatelet medications are at the discretion of treating cardiologist.
Timepoint [2] 334433 0
Antiplatelet medications are commenced by the treating cardiologist at least 24 hours prior to coronary intervention. Baseline IMR is measured prior to coronary artery stenting. IMR measurement is repeated after coronary stenting.

Eligibility
Key inclusion criteria
Patients who present to hospital with evidence of coronary artery disease and undergo coronary intervention.
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients are excluded if they have active inflammatory/autoimmune disorders, previous history of myocardial infarction or PCI of the culprit vessel in the previous 12 months, previous coronary artery bypass graft surgery, severe renal impairment (eGFR <30ml/min), severe left ventricular dysfunction (ejection fraction <35%), contraindication to prolonged dual antiplatelet therapy, and significant valvular heart disease.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis
Statistical analysis is performed using SPSS statistical software system. Continuous variables are summarised as mean+/-SD and are compared with the Student t test. Non-parametric tests are used where appropriate. Normality of data is assessed with the Kolmogorov-Smironov statistic. Logarithmic transformation of data is performed for non-normally distributed data. A Pearson product-moment correlation coefficient is computed to assess the relationship between HsCRP, peak troponin and IMR of culprit vessels.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 7924 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment postcode(s) [1] 15886 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 296337 0
Hospital
Name [1] 296337 0
St Vincent's Hospital Melbourne
Address [1] 296337 0
41 Victoria Parade, Fitzroy VIC 3065
Country [1] 296337 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital Melbourne
Address
41 Victoria Parade, Fitzroy VIC 3065
Country
Australia
Secondary sponsor category [1] 295267 0
None
Name [1] 295267 0
Address [1] 295267 0
Country [1] 295267 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297568 0
St Vincent's Melbourne HREC
Ethics committee address [1] 297568 0
41 Victoria Parade, Fitzroy VIC 3065
Ethics committee country [1] 297568 0
Australia
Date submitted for ethics approval [1] 297568 0
12/01/2010
Approval date [1] 297568 0
22/03/2010
Ethics approval number [1] 297568 0
HRECA 010-10

Summary
Brief summary
Myocardial infarction (‘Heart attack’) remains a significant cause of morbidity and mortality. Despite re-opening blocked heart arteries, there is still a group of patients that have a worse outcome due to disease of smaller arteries, not visible with conventional diagnostic x-ray imaging. A tool that directly measures involvement of the smaller arteries at the time of the initial heart attack would therefore be desirable. The index of microvascular resistance is such a technique that uses a special pressure wire to look at changes in flow in heart arteries in order to calculate resistance within the smaller vessels. We plan to use this tool in patients with heart attacks to assess the small vessel (microcirculatory) involvement. We will also take a small amount of blood to look at specific blood tests that show degrees of inflammation and the function of blood cells. The blood sample will be stored in -80C freezer for various inflammatory markers tests at a later stage. We will also assess the effect of medications given for heart attacks on the small blood vessel function. The goal of this study is to investigate factors that influence the function of the small blood vessels. We will utilise this technique in order to improve treatment for all patients who have a heart attack and improve our understanding of the disease process and ultimately provide new treament options that may benefit the Australian community.
Trial website
Trial related presentations / publications
None
Public notes
Blood samples will be collected during coronary intervention procedure and will stored in -80C freezer for various inflammatory markers tests at a later stage. These tests will be run in batches at the completion of study recruitment.

Contacts
Principal investigator
Name 74466 0
A/Prof Jamie Layland
Address 74466 0
St Vincent's Hospital Melbourne
41 Victoria Parade
Fitzroy VIC 3065
Country 74466 0
Australia
Phone 74466 0
+61 3 9231 2211
Fax 74466 0
Email 74466 0
JLayland@phcn.vic.gov.au
Contact person for public queries
Name 74467 0
A/Prof Jamie Layland
Address 74467 0
St Vincent's Hospital Melbourne
41 Victoria Parade
Fitzroy VIC 3065
Country 74467 0
Australia
Phone 74467 0
+61 3 9231 2211
Fax 74467 0
Email 74467 0
JLayland@phcn.vic.gov.au
Contact person for scientific queries
Name 74468 0
A/Prof Jamie Layland
Address 74468 0
St Vincent's Hospital Melbourne
41 Victoria Parade
Fitzroy VIC 3065
Country 74468 0
Australia
Phone 74468 0
+61 3 9231 2211
Fax 74468 0
Email 74468 0
JLayland@phcn.vic.gov.au

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary