PVDOMICS STUDY - FORMS TABLE OF CONTENTS

 

NOTES:

·         Administrative management forms and data are not included.

·         Some forms are included for informational purposes only.

·         PVD Status/WSPH WHO Group cases were adjudicated by a PVD committee of physician investigators.

·         Core adjudicated study results are provided where applicable.

 

Form #

Version Date

CENTER PARTICIPANT FORMS

Notes

100

10/25/2017

Initial Enrollment Form (includes Inclusion and Exclusion Review questions)

 

102

08/03/2021

08/03/2021

PVD Assessment Form

 

102C-Comparators Only Assessment

 

103

10/30/2018

Non-PVD Comorbidity, Medical and Surgical History Form

 

104

04/04/2016

Demographics, Employment and Income Form

 

105

08/23/2018

Exposure History Form

 

106

11/09/2017

Thrombophilia History Form

 

107

06/17/2021

Review of Family History of Pulmonary Hypertension Form

 

110

06/23/2017

PH and Concomitant Medications Form

 

115

05/08/2019

Functional Class

 

120

06/23/2017

Study Visit Vital Signs Form

 

121

02/21/2018

Female Reproductive History Form

 

131

07/20/2017

Waist/Hip Measure Form

 

132

06/08/2017

Height, Weight, and Bioelectrical Impedance (BIA) Form

 

133

06/15/2018

6 Minute Walk Test (6MWT) Form

 

150

01/10/2019

Clinical Center Participant Initial Sleep Form

 

151

09/19/2016

Participant Sleep Study Questionnaire

 

152

01/10/2019

Clinical Center Sleep Download and Transmittal Form

 

155

04/04/2018

Clinical Center Alternative Sleep Study Report Transmission Form

 

170

05/25/2016

Survey Instrument (SF-36v2) Form

 

171

04/05/2016

Minnesota Living With Heart Failure® Questionnaire (MLHF) 

 

172

04/08/2016

emPHasis-10 Quality of Life Form

 

185

10/01/2018

Participant Two-Week Event Assessment

 

187

01/09/2023

Annual Follow-up

 

 

 

 

 

200

08/22/2017

Center CBC w Diff Results

 

201

01/11/2018

Center Complete Metabolic Panel (CMP) Results

 

202

09/17/2019

Center Antinuclear Antibody (ANA) Results

 

203

06/23/2017

Center HIV Antigen/Antibody Screen Result

 

204

02/23/2018

Center Hepatitis Screen Result

 

205

06/23/2017

Center Prothrombin Time (PT) Results

 

207

11/10/2017

Center Arterial Blood Gases (ABG) Results

 

 

 

 

 

245

01/20/2017

Electrocardiogram (ECG) Data Transmittal For

 

250

02/27/2019

Echocardiogram (ECHO) Transmittal Form

 

251

08/31/2017

Cardiac MRI Transmittal Form

 

252

02/22/2018

Center Chest CT Scan Data Transmittal Form

 

253

07/05/2017

Center Historical Chest CT Data Transmittal Form

 

254

07/09/2018

Center Ventilation/Perfusion (V/Q) Scant

 

270

10/27/2017

Pulmonary Function Testing

 

271

10/10/2017

Historical Pulmonary Function Testing

 

280

02/27/2019

Clinical Center Right Heart Catheterization (RHC)

 

290

290A

08/01/2018

05/24/2018

Center Cycle Ergometer Non-Invasive CPET Procedure Notes

Addendum to Center Cycle Ergometer Non-Invasive CPET Procedure Notes

 

291

291A

08/01/2018

05/24/2018

Center Cycle Ergometer Invasive CPET Procedure Notes

Addendum to Center Cycle Ergometer Invasive CPET Procedure Notes

 

 

 

 

 

300

02/16/2017

Center Blood Collection 1 – Drawing Samples Form

Form provided for information only. No data provided.

301

02/16/2017

Center Blood Collection 1 – Processing Samples Form

Form provided for information only. No data provided.

304

03/03/2020

Center Blood Collection 2 – Drawing “Rest” Samples Form

Form provided for information only. No data provided.

305

05/23/2018

Center Blood Collection 2 – Processing PAXgene® “Rest” Sample Form

Form provided for information only. No data provided.

306

05/23/2018

Center Blood Collection 2 – Processing “Rest” Samples into Cryovials Form

Form provided for information only. No data provided.

307

05/23/2018

Center Blood Collection 2 – Drawing “Rest, Peak and Post” Samples Form

Form provided for information only. No data provided.

308

05/23/2018

Center Blood Collection 2 – Processing PAXgene® “Rest, Peak and Post” Sample Form

Form provided for information only. No data provided.

309

05/23/2018

Center Blood Collection 2 – Processing “Rest, Peak and Post” Samples into Cryovials

Form provided for information only. No data provided.

320

02/16/2017

Center Urine Collection 1 Sample

Form provided for information only. No data provided.

321

02/16/2017

Center Urine Collection 1 Processing Sample

Form provided for information only. No data provided.

 

 

 

 

400

03/22/2018

Event(s) Notification Form – Events occurring within 8 week study period

 

Form #

Version Date

DCC CORE FORMS ONLY

Notes

153

04/02/2018

Sleep Core Receipt and QA Review

 

156

11/13/2018

Sleep Core Review of Alternative Sleep Study

 

220

12/20/2019

Clinical Chemistry Core Results Data Transmission

 

246

08/06/2018

CPC Electrocardiogram (ECG) Core Results

 

246A

02/08/2024

CPC Electrocardiogram (ECG) Extra Measures

Results will be provided by an RFA team when finalized.

260

10/26/2017

ICL Core Echocardiogram (ECHO) Results Data Transmission

 

261

10/19/2018

ICL Core Cardiac MRI Imaging Results Data Transmission

 

262

05/14/2020

Lung Imaging Core (CT) Results

 

262A

03/03/2021

Lung Imaging Core PA Measurements

 

262B

12/12/2023

Lung Imaging Core (CT) CTEPH Measures

Results will be provided by an RFA team when finalized.

283

08/02/2018

Core Right Heart Catheterization (RHC) Results

 

292

03/05/2021

CPC CPET Results