Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00404

2 Trial Registration Date

2014-04-08

i Registration Status

Prospective

3 Secondary IDs

CRE-2013.619

4 Source(s) of Funding

Pending for HMRF grant approval

5 Primary Sponsor

The Chinese University of Hong Kong

6 Secondary Sponsor

N/A

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

SHANG, Qing

ii Address

Department of Medicine & Therapeutics, CUHK

iii Phone

2632 3840

iv Email

qingshang@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

SHANG, Qing

ii Address

Department of Medicine & Therapeutics, CUHK

iii Phone

2632 3840

iv Email

qingshang@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

9 Official Scientific Title of the Study

Non-invasive Assessment of Cardiovascular Reserve in Patients with Systemic Autoimmune Diseases

10 Public Title

Non-invasive Assessment of Cardiovascular Reserve in Patients with Systemic Autoimmune Diseases

i Public Title in Chinese 研究名稱

無創評估系統性自體免疫性疾病患者的心血管儲備功能

11 Short Title (Optional)

Cardiovascualr Reserve in SLE & PsA

12 Countries of Recruitment

Hong Kong Special Administrative Region, People's Republic of China

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2014-01-20

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Systemic lupus erythematosus, Psoriatic arthritis

15 Intervention

i Types of intervention

Other

Please specify

None

ii Description/ name of Intervention/article

N/A

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

N/A

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

N/A

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Patients with SLE (fulfilling the American College of Rheumatology criteria of SLE29) or PsA (fulfilling the criteria of the Classification of Psoriatic Arthritis criteria30) are considered eligible for the this study if they are at least 18 years old. The patients should have no symptoms or signs of heart disease and have a normal resting 12-lead echocardiogram. Control subjects are enrolled if they are considered to have a low probability of coronary artery disease on clinical grounds and have a normal exercise stress echocardiogram. All participants must be able to provide informed written consent.

ii Exclusion Criteria

Exclusion criteria are hypertension, significant atrial or ventricular arrhythmia, significant valvular diseases (>moderate severity), significant coronary artery disease, prior history of myocardial infarction, impaired LV systolic function (ejection fraction<50%, or any regional wall motion abnormality), pericardial disease and unable to exercise.

iii Age Minimum

18 years

iv Age Maximum

N/A

v Gender

Both Male and Female

18 Study Type

Observational

19 Study Design

i Randomization

Non-randomized

Please specify

ii Nature of control

Not Applicable

iii Degree of masking

Not Applicable

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2014-12-22

21 Target Sample Size

195

22 Recruitment Status

Unknown

23 Primary Outcome

Cardiovascular reserve in different group

24 Secondary Outcome

N/A

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2016-11-15

27 Primary Registry and Trial Identifying Number

ChiCTR-ONRC-14004476

28 Date of Registration in Primary Registry

2014-04-10

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Trial History Detail on 2015-12-19