Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000450112
Ethics application status
Approved
Date submitted
6/03/2019
Date registered
19/03/2019
Date last updated
5/07/2021
Date data sharing statement initially provided
19/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The Macro- and Micro-circulation in Coronary Heart Disease
Scientific title
Assessing the macro- and micro-circulation and their relation to cardiovascular events in patients with coronary heart disease
Secondary ID [1] 297460 0
None
Universal Trial Number (UTN)
Trial acronym
None
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Coronary heart disease 311646 0
Condition category
Condition code
Cardiovascular 310270 310270 0 0
Coronary heart disease

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
5
Target follow-up type
Years
Description of intervention(s) / exposure
Patients referred to the cardiac catheter laboratory are invited to participate in the study. Invasive physiology testing including fractional flow reserve and index of micro-circulatory resistance will be measured in all participants. Coronary pressure wires will be inserted into the coronary arteries via a guiding catheter, and measurements including pressure and mean saline transit time will be measured under both resting and hyperaemic conditions.

Every 5th presenting patient will also have endothelial function and wall shear stress assessed. Patients will be followed up to 5 years, and be assessed for recurrent chest pain, revascularization, myocardial infarction, and death.
Intervention code [1] 313715 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319164 0
Combined end point of cardiac death, myocardial infarction, hospitalization for heart failure, or revascularization will be collected via telephone follow-up +/- data linkage to medical records.
Timepoint [1] 319164 0
1 year
Secondary outcome [1] 367153 0
Cardiac death via telephone follow-up +/- data linkage to medical records.
Timepoint [1] 367153 0
1,2, and 5 years
Secondary outcome [2] 367154 0
Myocardial infarction via telephone follow-up +/- data linkage to medical records.
Timepoint [2] 367154 0
1,2, and 5 years
Secondary outcome [3] 367155 0
Revascularization via telephone follow-up +/- data linkage to medical records.
Timepoint [3] 367155 0
1,2, and 5 years
Secondary outcome [4] 367156 0
Canadian Cardiovascular Society Angina Grade
Timepoint [4] 367156 0
1,2,and 5 years
Secondary outcome [5] 367157 0
Seattle Angina Questionnaire Score
Timepoint [5] 367157 0
1,2, and 5 years
Secondary outcome [6] 367210 0
Hospitalization for heart failure via telephone follow-up +/- data linkage to medical records.
Timepoint [6] 367210 0
1,2, and 5 years

Eligibility
Key inclusion criteria
Patients referred to the cardiac catheter laboratory for coronary angiography or percutaneous coronary intervention
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy, cardiogenic shock, contraindication to adenosine, severe asthma, heavily calcified or tortuous vessels leading to inability to advance pressure wire

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
600 patients are anticipated to be enrolled into the study, based on an estimated recruitment rate of 4 patients per week (across 2 sites) over 3 years. This represents a similar study population size compared to the multi-center PROSPECT observational study.

Patients will be followed up for up to 5 years for cardiac death, myocardial infarction, revascularization, hospitalization for heart failure, and recurrent chest pain. Cox regression analysis will be used to identify both univariable and multivariable predictors of MACE in the entire study cohort.

The study cohort will be divided into those with microcirculatory disease and those without. The baseline characteristics of the two groups will be compared using the independent samples t test for continuous variables, and Pearson’s chi square test for dichotomous variables. The outcome of major adverse cardiac events (including death, MI, or revascularization) will be compared between the two groups using the Kaplan-Meier method.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
22/03/2019
Actual
6/06/2019
Date of last participant enrolment
Anticipated
30/01/2022
Actual
Date of last data collection
Anticipated
31/01/2027
Actual
Sample size
Target
600
Accrual to date
65
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 13207 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 13208 0
Concord Repatriation Hospital - Concord
Recruitment postcode(s) [1] 25764 0
2050 - Camperdown
Recruitment postcode(s) [2] 25765 0
2139 - Concord

Funding & Sponsors
Funding source category [1] 302030 0
Hospital
Name [1] 302030 0
Royal Prince Alfred Hospital (Sydney Local Health D=iIstrict)
Country [1] 302030 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital (Sydney Local Health District)
Address
50 Missenden Rd, Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 301828 0
None
Name [1] 301828 0
Address [1] 301828 0
Country [1] 301828 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302711 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 302711 0
Ethics committee country [1] 302711 0
Australia
Date submitted for ethics approval [1] 302711 0
08/11/2018
Approval date [1] 302711 0
22/03/2019
Ethics approval number [1] 302711 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91130 0
A/Prof Martin Ng
Address 91130 0
Royal Prince Alfred Hospital
50 Missenden Road, Camperdown, NSW 2050
Country 91130 0
Australia
Phone 91130 0
+61 2 95156111
Fax 91130 0
Email 91130 0
[email protected]
Contact person for public queries
Name 91131 0
Christopher Wong
Address 91131 0
Royal Prince Alfred Hospital
50 Missenden Road, Camperdown, NSW 2050
Country 91131 0
Australia
Phone 91131 0
+61 2 95156111
Fax 91131 0
Email 91131 0
[email protected]
Contact person for scientific queries
Name 91132 0
Christopher Wong
Address 91132 0
Royal Prince Alfred Hospital
50 Missenden Road, Camperdown, NSW 2050
Country 91132 0
Australia
Phone 91132 0
+61 2 95156111
Fax 91132 0
Email 91132 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All baseline characteristics, physiology measurements, outcomes.
When will data be available (start and end dates)?
25/03/2019 to 31/01/2027
Available to whom?
Available to journal reviewers and authors of meta-analyses if requested
Available for what types of analyses?
Reviews and meta-analyses
How or where can data be obtained?
Emailed in individually unidentifiable form


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
Dimensions AIFractional Flow Reserve and Instantaneous Wave-Free Ratio Predict Pathological Wall Shear Stress in Coronary Arteries: Implications for Understanding the Pathophysiological Impact of Functionally Significant Coronary Stenoses2022https://doi.org/10.1161/jaha.121.023502
N.B. These documents automatically identified may not have been verified by the study sponsor.