Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00320

2 Trial Registration Date

2012-05-17

i Registration Status

Prospective

3 Secondary IDs

Nil

4 Source(s) of Funding

Nil

5 Primary Sponsor

Nil

6 Secondary Sponsor

Nil

Function

Please specify

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

i Name

Alex Pui Wai LEE

ii Address

Division of Cardiology, Department of Medicine & Therapeutics, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong

iii Phone

852-2632 3140

iv Email

alexpwlee@cuhk.edu.hk

v Affiliation

Department of Medicine & Therapeutics, The Chinese Univerity of Hong Kong

vi Country

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

i Name

Qing SHANG

ii Address

Division of Cardiology, Department of Medicine & Therapeutics, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong

iii Phone

852-2632 3840

iv Email

qingshang@cuhk.edu.hk

v Affiliation

Department of Medicine & Therapeutics, The Chinese Univerity of Hong Kong

vi Country

9 Official Scientific Title of the Study

Cardiovascular Reserve in Patients with Systemic Autoimmune Diseases

10 Public Title

Cardiovascular Reserve in Patients with Systemic Autoimmune Diseases

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

Nil

12 Countries of Recruitment

Hong Kong SAR, China

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2012-03-21

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Rheumatic diseases

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 or PsA, Control subjects who are considered to have a low probability of coronary artery disease on clinical grounds and have a normal exercise stress echocardiogram.

ii Exclusion Criteria

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

2012-07-04

21 Target Sample Size

150

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

1. Changes in resting cardiac function and functional reserve during exercise in 3-dimensional planes
2. Increased arterial stiffness in resting and impaired vascular reserve during exercise
3. Association among early cardiovascular dysfunction, impaired functional reserve during exercise and biomarkers

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

2014-11-24

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

Nil

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Trial History Detail on 2012-05-17