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

Exclusion criteria are uncontrolled severe hypertension (Resting systolic blood pressure is 180mmHg or greater or diastolic blood pressure is 120mmHg or higher), 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

Suspended

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

ChiCTR-ONC-12002365

28 Date of Registration in Primary Registry

2012-07-22

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

Nil

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Trial History Detail on 2013-10-23