CDE Detailed Report

Disease: Friedreich's Ataxia
Sub-Domain: Clinical Event End Points
CRF: Cardiac End Points

Displaying 1 - 12 of 12
CDE ID CDE Name Variable Name Definition Short Description Question Text Permissible Values Description Data Type Disease Specific Instructions Disease Specific Reference Population Classification (e.g., Core) Version Number Version Date CRF Name (CRF Module / Guideline) Sub Domain Name Domain Name Size Input Restrictions Min Value Max Value Measurement Type External Id Loinc External Id Snomed External Id caDSR External Id CDISC
C59007 American Heart Association heart failure stage classification status AHAHeartFailStageClassStatus Status of the participant's/subject's stage heart failure according to the American Heart Association (AHA) Stage of Heart Failure classifications Status of the participant's/subject's stage heart failure according to the American Heart Association (AHA) Stage of Heart Failure classifications Classify the subject using the AHA Stage of Heart Failure A;B;D;C A. No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath). No objective evidence of cardiovascular disease. No symptoms and no limitation in ordinary physical activity;B. Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath). Objective evidence of minimal cardiovascular disease. Mild symptoms and slight limitation during ordinary activity. Comfortable at rest.;D. Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases. Objective evidence of severe cardiovascular disease. Severe limitations. Experience symptoms even while at rest.;C. Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. Objective evidence of moderately severe cardiovascular disease. Marked limitation in activity due to symptoms, even during less-than-ordinary activity. Comfortable only at rest Alphanumeric Hunt SA, et al. Abraham WT, Chin MH, Feldman AM, Francis GS, Ganiats TG, Jessup M, Konstam MA, Mancini DM, Michl K, Oates JA, Rahko PS, Silver MA, Stevenson LW, Yancy CW, Antman EM, Smith SC Jr, Adams CD, Anderson JL, Faxon DP, Fuster V, Halperin JL, Hiratzka LF, Jacobs AK, Nishimura R, Ornato JP, Page RL, Riegel B; American College of Cardiology; American Heart Association Task Force on Practice Guidelines; American College of Chest Physicians; International Society for Heart and Lung Transplantation; Heart Rhythm Society. ACC/AHA 2005 Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the Adult: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Update the 2001 Guidelines for the Evaluation and Management of Heart Failure): developed in collaboration with the American College of Chest Physicians and the International Society for Heart and Lung Transplantation: endorsed by the Heart Rhythm Society. Circulation. 2005;112(12):e154-235. <br /><br />Hunt SA; American College of Cardiology; American Heart Association Task Force on Practice Guidelines (Writing Committee to Update the 2001 Guidelines for the Evaluation and Management of Heart Failure). ACC/AHA 2005 guideline update for the diagnosis and management of chronic heart failure in the adult: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Update the 2001 Guidelines for the Evaluation and Management of Heart Failure). J Am Coll Cardiol. 2005 Sep 20;46(6):e1-82. Erratum in: J Am Coll Cardiol. 2006 Apr 7;47(7):1503-1505. Adult;Pediatric Supplemental 3.00 2013-07-11 15:03:49.2 Cardiac End Points Clinical Event End Points Outcomes and End Points

Single Pre-Defined Value Selected

C59008 Hospital admission start date HospitlAdmissStartDate Date the participant/subject was admitted to the hospital Date the participant/subject was admitted to the hospital Indicate the start date of participant's hospitalization. Date or Date & Time

Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (http://www.iso.org/iso/home.html). The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.)

Adult;Pediatric Supplemental 1.00 2021-06-11 11:38:04.0 Cardiac End Points Clinical Event End Points Outcomes and End Points

Free-Form Entry

C58685 Patient ambulatory status PtAmbStat Status indicating whether the patient is ambulatory or not. Status indicating whether the patient is ambulatory or not. Indicate the ambulatory status of patient Ambulatory;Non-ambulatory Ambulatory;Non-ambulatory Alphanumeric Adult;Pediatric Core 1.00 2020-04-21 15:28:04.0 Cardiac End Points Clinical Event End Points Outcomes and End Points

Single Pre-Defined Value Selected

C58686 Heart palpitation history indicator HrtPalpHistInd Indicator of whether the patient has a history of heart palpitations. Indicator of whether the patient has a history of heart palpitations. Is there a history of palpitations? No;Yes No;Yes Alphanumeric Adult;Pediatric Core 1.00 2020-04-21 16:09:42.0 Cardiac End Points Clinical Event End Points Outcomes and End Points

Single Pre-Defined Value Selected

C58687 Heart symptomatic arrhythmias atrial origin history indicator HrtSymtpmArthmAtrOrigHistInd Indicator of whether the patient has a history of symptomatic arryhtmias documented to be of atrial origin. Indicator of whether the patient has a history of symptomatic arryhtmias documented to be of atrial origin. Is there a history of symptomatic arrhythmias documented to be of atrial origin? No;Yes No;Yes Alphanumeric Adult;Pediatric Core 1.00 2020-04-21 17:06:32.0 Cardiac End Points Clinical Event End Points Outcomes and End Points

Single Pre-Defined Value Selected

C58688 Heart symptomatic arrhythmias ventricular origin history indicator HrtSymtpmArthmVentOrigHistInd Indicator of whether the patient has a history of symptomatic arryhtmias documented to be of ventricular origin. Indicator of whether the patient has a history of symptomatic arryhtmias documented to be of ventricular origin. Is there a history of symptomatic arrhythmias documented of ventricular origin? No;Yes No;Yes Alphanumeric Adult;Pediatric Core 1.00 2020-04-21 17:08:29.0 Cardiac End Points Clinical Event End Points Outcomes and End Points

Single Pre-Defined Value Selected

C58689 Chest discomfort cardiac cause history indicator ChstDscmftCrdcCauseHistInd Indicator of whether the patient has a history of chest discomfort that is suggestive of a cardiac cause. Indicator of whether the patient has a history of chest discomfort that is suggestive of a cardiac cause. Is there a history of chest discomfort suggestive of a cardiac cause? No;Yes No;Yes Alphanumeric Adult;Pediatric Core 1.00 2020-04-21 17:10:31.0 Cardiac End Points Clinical Event End Points Outcomes and End Points

Single Pre-Defined Value Selected

C58690 Syncope history indicator SyncopeHistInd Indicator of whether the patient has a history of syncope. Indicator of whether the patient has a history of syncope. Is there a history of syncope? No;Yes No;Yes Alphanumeric Adult;Pediatric Core 1.00 2020-04-21 17:12:19.0 Cardiac End Points Clinical Event End Points Outcomes and End Points

Single Pre-Defined Value Selected

C58691 Dizziness near syncope history indicator DizzyNearSyncopeHistInd Indicator of whether the patient has a history of dizziness or of near syncope Indicator of whether the patient has a history of dizziness or of near syncope Is there a history of dizziness or near syncope? No;Yes No;Yes Alphanumeric Adult;Pediatric Core 1.00 2020-04-21 17:13:27.0 Cardiac End Points Clinical Event End Points Outcomes and End Points

Single Pre-Defined Value Selected

C10607 Hospitalization past year count HospitPastYrCt Count of all hospitalizations the participant/subject had within the past year Count of all hospitalizations the participant/subject had within the past year Indicate the number of hospitalizations the participant had in the past year. Numeric Values

Record the total number of hospitalizations for the past year.

No references available. Adult;Pediatric Supplemental 4.00 2021-06-11 11:34:45.0 Cardiac End Points Clinical Event End Points Outcomes and End Points

Free-Form Entry

C10609 Hospitalization reason HospitRsn Reason why the participant/subject was hospitalized, excluding all surgeries Reason why the participant/subject was hospitalized, excluding all surgeries Indicate cause for hospitalization. Cardiovascular;Other, specify Cardiovascular;Other, specify Alphanumeric

Record the reason for each hospitalization within the past year.

No references available. Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Cardiac End Points Clinical Event End Points Outcomes and End Points

Multiple Pre-Defined Values Selected

C18805 Hospitalization other text HospitOTH The free-text field related to 'Hospitalization reason' specifying other text. Reason why the participant/subject was hospitalized, excluding all surgeries The free-text field related to 'Hospitalization reason' specifying other text. Reason why the participant/subject was hospitalized, excluding all surgeries Other, specify Alphanumeric

Record the reason for each hospitalization within the past year

No references available Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Cardiac End Points Clinical Event End Points Outcomes and End Points 4000

Free-Form Entry

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