An observational study in Acute Coronary Syndrome, Heart Failure and Coronary Artery Disease, sponsored by University Health Network, Toronto. Enrolling by invitation at 1 site in Qatar. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-04.
Sponsored by University Health Network, Toronto · Observational
The ICRR is a health services registry to establish the quality of CR delivery, and the effectiveness in terms of patient outcomes, in low-resource settings. The purposes of the registry are care optimization, evidentiary support for CR advocacy / policy, and research.
All programs in low-resource settings will be welcome to participate at no cost. Programs will follow procedures approved by their local ethics board for collection of program and patient-reported variables. Assessments occur pre-cardiac rehabilitation (CR), post-CR and annually thereafter.
The user sub-committee has a formal site on-boarding process. Participating sites will be encouraged to enter data on all patients meeting inclusion / exclusion criteria to reduce bias. Prospective / concurrent data collection will be encouraged, to support quality improvement activities.
The company Dendrite will host the registry and ensure data security. Privacy protections will be in place, and no identifying information such as names will be entered into the registry. Data entered from sites into the registry is secured through encryption added to secure HTTP, done using Transport Layer Security. Stored data is also encrypted using InterSystems Cache database software.
There is an ICRR program survey assessing structural CR indicators. The registry variable list for patient-level data was developed based on recommendations of the Core Outcome Set-STAndards for Development (COS-STAD), through a delphi process. The final variable list and data dictionary can be found here: https://globalcardiacrehab.com/ICRR-Governance.
There are 10 program-reported variables and 16 patient-reported variables (some variables are assessed at multiple time points), assessed pre-program, post-program (dependent upon duration of each program) and each year from initial assessment (until patients expire or are unable to complete the assessments, which is ascertained by the program, or patient opt-out/withdrawal). Sites can arrange electronic data capture for the program-reported variables to contribute data to the registry, rather than manual electronic entry.
Descriptive statistics (i.e. means and standard deviations for continuous variables and frequencies with percentages for categorical variables) will be used to describe the quality of care (outcomes below). For testing change in patient outcomes pre to post-program, paired t-tests will also be used for continuous variables and chi-square test for categorical variables.
Univariate and multivariate approaches will be used to identify factors associated with outcomes, including the use of guideline-indicated therapies. Associations between patient characteristics and outcomes tested via logistic regression will be reported with odds ratios and 95% confidence intervals. Associations will be considered statistically significant when 2-sided α is \<0.05. Appropriate statistical corrections for repeated measures will be performed. To limit the influence of confounding, multivariate adjustment will be used, including propensity weighting, or other techniques. Risk adjustment (e.g., socioeconomic status, indication, comorbidities, age) will be undertaken.
The registry has a data quality dashboard which displays by site completeness of data entry at each assessment point, to help reduce bias. The registry has in-built minimum and maximum values for continuous variables to reduce data entry errors. The data dictionary clearly defines each variable, and new sites are trained prior to start. The registry is being usability tested prior to launch, and piloted in Qatar. The research sub-committee will oversee a data quality process; Data audits may be supported by a registry database analyst / professional statistician.
Patient perspectives were considered in the development of the variable list and outcomes. A registry page for patients is in development (https://globalcardiacrehab.com/ICRR-for-Patients). Patients have a voice on ICRR's user sub-committee. Patients providing data pre and post-program may receive a lay summary of their progress. Lay summaries of annual registry reports may be shared with interested patients.
1,488 studies on the registry are indexed under Acute Coronary Syndrome; 273 are open to participants now.
This study's planned enrollment of 7,000 is above the median of 500 across 590 observational studies indexed under Acute Coronary Syndrome.
Browse Acute Coronary Syndrome studies →University Health Network, Toronto is the lead sponsor of 1,438 studies on the registry; 297 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
Coronary heart disease patients who are indicated for CR are eligible for registry inclusion (e.g., acute coronary syndrome +/- revascularization, heart failure, stable coronary artery disease +/- valve or rhythm conditions); there are some exclusions to CR eligibility such as inability to ambulate.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
SITES:
Exclusion Criteria:
SITES:
-program cannot enter data in English
PATIENTS:
A CR program is defined as one that offers initial assessment, structured exercise (can be supervised or unsupervised) and at least one other strategy to control risk factors. The registry pertains to phase II CR. Quality of care and patient outcomes are benchmarked with other countries anonymously, through 2 registry dashboards (real-time). The dashboards will also show change over time in 6-month increments; Sites will be encouraged to continue to provide data on new patients until all indicators show quality as possible. Sites will be supported in quality improvement by the ICRR user sub-committee. High-performing programs will be recognized on ICRR's website and ICCPR's social media accounts. This mechanism may be used in future to support program accreditation.
Also known as: quality improvement initiatives, feedback
Mortality
all-cause mortality, assessed via phone call
Time frame: assessed annually from initial assessment date until patient expiry or withdrawal; there is no planned end date to registry but we estimate this will be assessed at 5 years
Morbidity
CV event or procedure, emergency department visit for cardiac cause, or any cause hospitalization, and/or other new health condition assessed via self-report
Time frame: assessed annually from initial assessment date until patient expiry or withdrawal; there is no planned end date to registry but we estimate this will be assessed at 5 years
Cardiac Symptoms
frequency of shortness of breath, dizziness, or chest pain in past month, assessed via self-report item (investigator-generated item based on https://www.ichom.org/portfolio/coronary-artery-disease/)
Time frame: assessed annually from initial assessment date until patient expiry or withdrawal; there is no planned end date to registry but we estimate this will be assessed at 5 years
Functional capacity
peak METs, which could be calculated based on exercise test (treadmill or bike), Duke Activity Status Index, or 6-minute walk test
Time frame: pre and post-CR program (dependent upon program length, but globally the median is 8 weeks)
Low-density lipoprotein
in mmol/L or mg/dL from lab report
Time frame: pre and post-CR program (dependent upon program length, but globally the median is 8 weeks)
Body mass index
weight and height will be combined to report BMI in kg/m\^2
Time frame: pre and post-CR program (dependent upon program length, but globally the median is 8 weeks)
Blood pressure
systolic and diastolic (mmHg), assessed manually or with a validated automated device
Time frame: pre and post-CR program (dependent upon program length, but globally the median is 8 weeks)
Work status
return-to-work, if applicable, assessed via self-report of work status
Time frame: pre and post-CR program (dependent upon program length, but globally the median is 8 weeks) & annually until patient expiry or withdrawal; there is no planned end date to registry but we estimate this will be assessed at 5 yea
Psychosocial well-being
quality of life (Cantril's ladder) \& depressive symptoms (PHQ-2)
Time frame: pre and post-CR program (dependent upon program length, but globally the median is 8 weeks) & annual until patient expiry or withdrawal; there is no planned end date to registry but we estimate this will be assessed at 5 years
Quality of life
Cantril's ladder of life (10 rungs)
Time frame: pre and post-CR program (dependent upon program length, but globally the median is 8 weeks) & annual until patient expiry or withdrawal; there is no planned end date to registry but we estimate this will be assessed at 5 years
Depressive symptoms
PHQ-2
Time frame: pre and post-CR program (dependent upon program length, but globally the median is 8 weeks) & annual until patient expiry or withdrawal; there is no planned end date to registry but we estimate this will be assessed at 5 years
Physical activity
self-report of minutes per week active to being at least slightly short of breath, assessed via self-report
Time frame: pre and post-CR program (dependent upon program length, but globally the median is 8 weeks) & annual until patient expiry or withdrawal; there is no planned end date to registry but we estimate this will be assessed at 5 years
Diet
average number of fruits and vegetables per day, via self-report
Time frame: pre and post-CR program (dependent upon program length, but globally the median is 8 weeks) & annual until patient expiry or withdrawal; there is no planned end date to registry but we estimate this will be assessed at 5 years
Medication adherence
frequency of taking heart pills as directed by physician in last month (5 point Likert scale from all the time to never), assessed via self-report
Time frame: pre and post-CR program (dependent upon program length, but globally the median is 8 weeks) & annual until patient expiry or withdrawal; there is no planned end date to registry but we estimate this will be assessed at 5 years
Tobacco use
self-report of never, current (last month), or former (use of tobacco more than 1 month prior)
Time frame: pre and post-CR program (dependent upon program length, but globally the median is 8 weeks) & annual until patient expiry or withdrawal; there is no planned end date to registry but we estimate this will be assessed at 5 years
Plan to share: Yes — The ICCR will explore potential public posting of anonymous registry data in a repository in future, to augment utility of the data through availability to the scientific community. Specific sites may also apply for ethics approval for administrative data linkage (e.g., clinical databases, imaging or lab data, government databases or surveys), which could enable cost-effectiveness analysis for example. Contributing sites may also apply for ethics approval to survey patients over and above registry assessments. Any secondary use of the data for research purposes will go through separate ethical review. Requests will be vetted by the ICRR research sub-committee. No data will be released that could identify patients. This may include sharing of aggregate data on common variables with other CR registries. This research may be published in peer-reviewed journals and presented at scholarly conferences.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: to be announced
Access criteria: The research sub-committee will develop a policy. Once approved, it will be posted at the website below
Data sharing details ↗ · globalcardiacrehab.com
Started Sep 2021 (actual). Primary completion is estimated for Jun 2036, 177 months after the start.
Of 243 non-industry observational studies under Acute Coronary Syndrome, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 71. This study's planned 177 months is above that.
Counting every sponsor, half of 277 studies reached it within 35 months; a quarter within 18 and three quarters within 68.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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