SCAD and CAE Study

Tags: LCBRU Study Category

Overview

Extension of the SCAD Study to include patients with Coronary Artery Aneurysms / Ectasia funded by ​ Rare Diseases Translational Research Collaboration (​Website).

• RD-TRC Study Guidance​
• RD-TRC Data Day Agenda​

Study Overview

CAE will be very similar to SCAD in the way that patients are recruited and the data that is collected.

1. Participants will register through the web portal. This has been created and is waiting for Rob to make the necessary amendments.
2. Participants from the web portal will be invited to take the online survey and will be entered into a registry.
3. Additional participants for the registry, identified through searching medical records, will be invited to fill out a paper copy of the same survey, which will be keyed into the system by a member of the CAE team.
4. The survey will be similar, but not the same, to the one for the SCAD study.
5. A sub-set of participants from the CAE Registry will be invited to attend a site for deep phenotyping.
6. Participants who are not invited for deep phenotyping will be sent a mouth swab for collecting a DNA sample.
7. Deep phenotyping will involve filling out a more detailed questionnaire in REDCap and take various other tests, including MRIs, echos, etc, and the taking of a blood sample.
8. Recruiting at the study will be undertaken at several site:
   • Leicester
   • Oxford
   • Cambridge
   • Guys and St Thomas'
   • Bristol
   • Royal Free

Status

?

Contacts

Principle Investigator

Dave Adlam

Investigator

Abi Al-Hussaini

RDCIT Training

Vera Matser

RDCIT Director

Roger James

IT Requirements

1. New online REDCap survey
2. Produce paper copy of survey
3. Copy of online survey as questionnaire for CAE staff to transcribe paper copies
4. Demographics checking for participant mailings at Leicester
5. New REDCap questionnaire for deep phenotyping on N3 survey
6. Administration and networking set up for external site connections to Deep phenotyping questionnaire.
7. Labels for mouth swab samples and associated consent form
8. Labels for blood samples and associated consent form
9. CiviCRM project for participant management
10. Recruitment Report
11. Data quality reports
12. CAE drive space for medical notes and images
13. Data extracts from REDCap and CiviCRM

Questionnaire

REDCap Summary (Probably)

Web Site

SCAD CAE Instance Live

Upload of Data to RDCIT OpenClinica Instance

• There are no specific data requirements for the RD-TRC, except that patient identifiable study data is stored in the RDCIT instance of OpenClinica by the end of the funding period (approx September 2016).
• There is a proposed data structure​ that is based on the data requirements of GenomicsEngland (GEL). This includes patient identiable details, consent, medical / family history, genetic / clinical tests, medication and more. There is, however, no formal link between RD-TRC and GEL and all fields that are mandatory in GEL are not mandatory for RD-TRC.
• To this we can create a data definition (CRF) to facilitate our study data.
• These data definitions (CRF) are published on the RDCIT OpenClinica site and reuse and collaboration are encouraged.

We are waiting for the requirements of data to be uploaded from Dave and Abi

Tickets

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