Trial Review

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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
Sex
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
23/04/2010
Date of last participant enrolment
Anticipated
Actual
3/06/2013
Date of last data collection
Anticipated
Actual
12/08/2014
Sample size
Target
76
Accrual to date
Final
74
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
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
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
Trial website
Trial related presentations / publications
Public notes

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
[email protected]
Contact person for public queries
Name 74467 0
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
[email protected]
Contact person for scientific queries
Name 74468 0
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
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseHigh-Sensitivity C-Reactive Protein Is a Predictor of Coronary Microvascular Dysfunction in Patients with Ischemic Heart Disease.2018https://dx.doi.org/10.3389/fcvm.2017.00081
N.B. These documents automatically identified may not have been verified by the study sponsor.