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SHOCK TRIAL

REGISTRATION FORM

Form 01

INSTRUCTIONS:	COMPLETE FOR ALL PATIENTS WITH SUSPECTED CARDIOGENIC 					SHOCK COMPLICATING ACUTE MYOCARDIAL INFARCTION.

						PLEASE COMPLETE ALL QUESTIONS BY EITHER CIRCLING THE 							CORRECT NUMBER OR ENTERING REQUIRED DATA


A.		IDENTIFICATION


A1.		Clinic Site Code and Patient I.D.
ID LABEL HERE
Sample Listing of Eight Patients

 MERGEFIELD TABLE лTABLE╗ NEXT лNext Record╗
A2.		Date of Admission to this hospital					___ ___ / ___ ___ / ___ ___
		(F1ADMITD is character and 								   MO		DAY	   YEAR
		F1ADM_D is numeric)
 MERGEFIELD TABLE лTABLE╗ NEXT лNext Record╗
A3.		Time of Admission to this hospital					___ ___:___ ___	
																   HRS	    MINS

							(circle one):						1.  AM		2.  PM		3. 24-hour clock

A4.		Type of Admission									1.  ER		2.  Elective		3.  Transfer
 MERGEFIELD TABLE лTABLE╗ NEXT лNext Record╗	
A5.		Patient's Date of Birth									___ ___ / ___ ___ / ___ ___
		(DOB_D is character and											MO		DAY	   YEAR
		DOB is numeric)
 MERGEFIELD TABLE лTABLE╗ NEXT лNext Record╗
A6.		Patient's Gender										1.	Male		2.	Female
 MERGEFIELD TABLE лTABLE╗ NEXT лNext Record╗	
A7.		Patient's Race 							1.  White		2.  Black		3.  Asian		4.  Other
 MERGEFIELD TABLE лTABLE╗ NEXT лNext Record╗	
 MERGEFIELD TABLE лTABLE╗ NEXT лNext Record╗
A8.		Is the patient Hispanic?								1.	No			2.	Yes
 MERGEFIELD TABLE лTABLE╗ NEXT лNext Record╗	
A9.		Date Form Completed									___ ___ / ___ ___ / ___ ___
		(COMP_D is character and										MO		DAY	   YEAR
		COMP_DT is numeric)
 MERGEFIELD TABLE лTABLE╗ NEXT лNext Record╗
A10.	Person Completing Form										______________________________
		[Omitted]																NAME (PLEASE PRINT CLEARLY)

B.	ELIGIBILITY

B1.	a.	Date of onset of index MI/symptoms 					___ ___ / ___ ___ / ___ ___
		(may be second MI during current illness, 						 MO		DAY	   YEAR
		  if it preceded shock onset.) 
		(ONSET_D is character and ONSET_DT is numeric)
 MERGEFIELD TABLE лTABLE╗ NEXT лNext Record╗
	b.	Time of onset of MI/symptoms						___ ___:___ ___	
																   HRS	    MINS

							(circle one):						1. AM		2. PM		3. 24-hour clock

B2.	a.	Date of onset of clinically suspected
		cardiogenic shock									___ ___ / ___ ___ / ___ ___
		(ONSETC_D is character and										MO		DAY	   YEAR
		ONSETC_DT is numeric)
 MERGEFIELD TABLE лTABLE╗ NEXT лNext Record╗
	b.  Time of onset of cardiogenic shock					___ ___:___ ___	
																   HRS	    MINS

							(circle one):						1. AM		2. PM		3. 24-hour clock

B3.	a.  Difference in times (B2 - B1)							___ ___ ___	HOURS
		(ROUND UP TO NEAREST HOUR.
		 Example: Record 3 hours, 16 minutes as 4 hours.)
 MERGEFIELD TABLE лTABLE╗ NEXT лNext Record╗
	b.  Is difference <  36 hours (d" 48 hours for Version 1)?1. No
    INELIGIBLE 
   & CONTINUE2. Yes MERGEFIELD TABLE лTABLE╗ NEXT лNext Record╗
 MERGEFIELD TABLE лTABLE╗ NEXT лNext Record╗
B4.  Clinical exclusion criteria present?1. No (Q.B5)2. Yes
     INELIGIBLE
     & CONTINUE MERGEFIELD TABLE лTABLE╗ NEXT лNext Record╗
		B4.1  IF YES, list numbers of all that apply
			   from box below								____	____	____	____




Clinical Exclusion Criteria

1.	Other severe systemic illness (e.g. metastatic neoplastic disease) including contraindications to cardiac surgery
2.	Active bleeding or other contraindications to heparin (.e.g., allergy)
3.	VSD / Papillary muscle or chordal rupture / Severe MR SYMBOL 224 \f "Wingdings" Complete Form S2, S3 as applicable
4.	Isolated right ventricular cardiogenic shock
5.	Shock due to other causes (i.e. hypovolemia, sepsis, anaphylaxis)
6.	Severe aortic stenosis or other severe valvular disease
7.	Known dilated cardiomyopathy (ischemic or other)
8.	Inability to obtain vascular access for catheterization
9.	Recent hemorrhage: e.g.  Hct fall > 15 percentage points < 24 hrs
10.	Tamponade SYMBOL 224 \f "Wingdings" Complete Form S4
11.	Shock due to Beta or Calcium Channel blockade 
12.	EKG does not qualify - i.e. non Q-wave MI or old LBBB
13.	Anoxic brain damage
14. 	Not a candidate for either PTCA or CABG (e.g., coronary anatomy known)
15.	Shock resulted from cardiac cath lab complication 
 MERGEFIELD TABLE лTABLE╗ NEXT лNext Record╗
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B5.	(Version 2.1 only) Lowest recorded systolic blood pressure prior to randomization (e.g., 60 SBP upon hospital arrival or lowest BP prior to vasopressors) 

   ___ ___ ___ mmHg MERGEFIELD TABLE лTABLE╗ NEXT лNext Record╗
B6.	a.  Was SBP < 90 mmHg  on two measurements   	  
           30 minutes apart before vasopressors?
1. No
2. Yes
-1.  Not
      Applicable MERGEFIELD TABLE лTABLE╗ NEXT лNext Record╗
	b.	Were vasopressors required to maintain 
		SBP > 90 mmHg?
1. No
2. Yes
 MERGEFIELD TABLE лTABLE╗ NEXT лNext Record╗
B7.	a.	Was urine output < 30 cc/hour?1. No2. Yes-9.  Not
      Available MERGEFIELD TABLE лTABLE╗ NEXT лNext Record╗
	b.	Was there evidence of cold, diaphoretic
		extremities?
1. No
2. Yes MERGEFIELD TABLE лTABLE╗ NEXT лNext Record╗
B8.		Was heart rate > 60 beats/minute (including
		 paced rhythms) (e" 80 beats/minute for 
             Version 1)?
1. No
2. Yes MERGEFIELD TABLE лTABLE╗ NEXT лNext Record╗
 MERGEFIELD TABLE лTABLE╗ NEXT лNext Record╗
B9.		Was Swan-Ganz catheterization done?1. No2. Yes (Q.B9.2)
 MERGEFIELD TABLE лTABLE╗ NEXT лNext Record╗
	B9.1	IF NO, 
			a.  (Version 2.1 only) Not performed because:
  			      1.	Patient died before Swan
				2.	Patient refused
				3.	Physician refused
				4.	Patient improved rapidly and did not need Swan
				5.	Other (Specify)____________________________
 MERGEFIELD TABLE лTABLE╗ NEXT лNext Record╗
 MERGEFIELD TABLE лTABLE╗ NEXT лNext Record╗
b.  (Version 2.1 only) Anterior MI with chest X- 
     Ray evidence of pulmonary congestion? 1.  No (Q.B10)
     INELIGIBLE
     & CONTINUE2. Yes (Q.B10) MERGEFIELD TABLE лTABLE╗ NEXT лNext Record╗
	B9.2	IF YES to B9,

				a.	Was pulmonary capillary wedge pressure 	
					> 15 mmHg?
1. No
2. Yes MERGEFIELD TABLE лTABLE╗ NEXT лNext Record╗
				b.	Was cardiac index < 2.2 l/min/m2?1. No2. Yes-9.  Not
      Done MERGEFIELD TABLE лTABLE╗ NEXT лNext Record╗
B10.	Were ALL of the following items checked YES:
 	B6 (a OR b), B7 (a OR b), B8, 
 	(B9.1b OR B9.2 (a AND b))?1.  No
     INELIGIBLE 
     & CONTINUE 2. Yes MERGEFIELD TABLE лTABLE╗ NEXT лNext Record╗
B11.  SHOCK TO RANDOMIZATION

		a.	(Version 2.1 only) Potential Date of Randomization				___ ___ / ___ ___ / ___ ___
			(STOR_D is character and STOR_DT is numeric)					MO		DAY	   YEAR
 MERGEFIELD TABLE лTABLE╗ NEXT лNext Record╗
		b.	(Version 2.1 only) Potential Time of Randomization					___ ___:___ ___	
											    										HRS	 MINS

								(circle one):							1. AM		2. PM		3. 24-hour clock

		c. Difference in times  (ROUND UP TO NEAREST HOUR       Example: Record 3 hours, 16 minutes as 4 hours.)
                   (For Version 1, this is the difference in randomization time and 
                   onset of cardiogenic shock time.  For Verison 2.1, this is the 
                   difference in potential randomization time and onset of cardiogenic 
                   shock time.) 
___ ___ ___ HOURS MERGEFIELD TABLE лTABLE╗ NEXT лNext Record╗

		d.  Is this difference (B11. c.1. or c.2.) < 12 hours? 1.  No
      INELIGIBLE 
      & CONTINUE2.  Yes MERGEFIELD TABLE лTABLE╗ NEXT лNext Record╗
B12.	Was written informed consent             obtained from patient?1. No 
    INELIGIBLE 2. Yes (Q.B12.2)3.  NA
     Ineligible        (END) MERGEFIELD TABLE лTABLE╗ NEXT лNext Record╗
		B12.1	IF NO, specify reason:		1.	Patient or proxy refused
												2.	Not obtainable, patient too sick or proxy not available
												3.	Not obtainable, patient expired
												4.	Patient's private physician refused
												5.	Other (specify) __________________________ (END)

 MERGEFIELD TABLE лTABLE╗ NEXT лNext Record╗
 MERGEFIELD TABLE лTABLE╗ NEXT лNext Record╗
		B12.2	(Version 2.1 only) IF YES, Did patient expire before randomization?	1.  No		2.  Yes 
																										(END)
 MERGEFIELD TABLE лTABLE╗ NEXT лNext Record╗
C.	RANDOMIZATION	

C1.		(Version 2.1 only) Was eligibility confirmed?1. No
INELIGIBLE2. Yes MERGEFIELD TABLE лTABLE╗ NEXT лNext Record╗
C2.	a.	Date of Randomization								___ ___ / ___ ___ / ___ ___
		(RANDOM_D is character and						   MO		DAY	   YEAR
		RANDTE is numeric)
 MERGEFIELD TABLE лTABLE╗ NEXT лNext Record╗
	b.	Time of Randomization								___ ___:___ ___
																   HRS	     MINS

				(circle one):									1. AM		2. PM		3. 24-hour clock

C3.		Trial Group Assignment								1.	Initial Medical		2.	Emergency  
																	Stabilization			Revascularization
 MERGEFIELD TABLE лTABLE╗ NEXT лNext Record╗
C4.		Confirmation Number									____ ____ ____ ____

Sample Listing of Eight Patients
 MERGEFIELD TABLE лTABLE╗ NEXT лNext Record╗



Version 1 questions not appearing on Version 2.1:

B7.c.	Was mental status abnormal,         
            consistent with low cerebral blood flow? 
1. No
2. Yes MERGEFIELD TABLE лTABLE╗ NEXT лNext Record╗
B9.1.c.     Place of Swan-Ganz procedure	                  1. ER		                     2. CCU Bed

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SHOCK TRIAL - Form 01 - Version 2.1 Date 01/10/95 - Page PAGE4


SHOCK TRIAL - Form 01 - Version 2.1 Date  01/10/95 - Page PAGE1




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