DATA COLLECTION FORM
Unique ID (As Generated Automatically Online.):…………………………………………
- REGISTRATION
State: / ……………………………………………………………..
City: / ……………………………………………………………..
Hospital: / ……………………………………………………………..
Patient Initials*: / ( (Initials of First Name, Middle Name & Surname Only )
Gender*: / Male / Female
Date of Birth Known*: / Yes / If Yes Mention Date ………../……../……… (DD/MM/YYYY)
/ No / Age : ……….Yrs
Registration Date* : / ……/……/………… (DD/MM/YY) ...... : …… (24 Hour Clock)
(at Registry Hospital)
Patient to be Registered in* : / MACE Registry / Yes / Informed consent Yes No
/ No / Please fill the reasons for non-inclusion
A1. REASONS FOR NON_INCLUSION
This questionairre needs to be completed in case the attending doctor suspects that the clinical diagnosis of Case is Acute Coronary Syndromeand patient is not included in the registry. The MACE Registry intends to understand the reasons for non-inclusion of such cases in the 'MACE' register.
Patient Admitted* / No / Yes
Plese tick the reasons for non-enrollment of this case in 'MACE' Registry.
Died before Consent could be obtained* / No / Yes / If Yes / ……/……/………… (DD/MM/YY) ...... : ……(24 Hour Clock)
Left hospital before Consent could be
obtained* / No / Yes
Patient / Relations refused consent* / No / Yes
Relations unavailable for consent* / No / Yes
Any Language barrier* / No / Yes
Miscellaneous* / No / Yes / If Yes / Specify Here: ………………………………
REGISTERED IN MACE REGISTRY
Patient Initials*: (Initials of First Name, Middle Name & Surname Only)
- DEMOGRAPHIC DETAILS
Residence*: / Urban / Semi-Urban / Rural
Postal Code: /
Current Employment Status*: / Professional,Big Business,Landlord,University Teacher
/ Trained,Clerical,Medium Bussiness Owner,Middle Level Farmer
/ Skilled Manual Labourer,Small Bussiness Owner,Small Farmer
/ Semi-Skilled Manual Labourer,Marginal LandOwner,Rickshaw Driver
/ Unskilled Manual Labourer,Landless Labourer
/ Housewife
/ Unemployed
/ Retired / Super Annuated / ………….Years………Months
Monthly Income ( Past 1 Year )* : / Rs. ………………………….
- INCLUSION/EXCLUSION CRITERIA
Inclusion Criteria* :
Acute Coronary Syndrome with definite ECG changes and/or enzyme elevation
Suspected of Unstable Angina but without definite ECG changes or elevation of cardiac enzymes.
Suspected case of ACS but no definite ECG changes and no ENZYME elevation. However the patient has a definite history of any one or more of the following: Ischemic Heart Disease ,Prior MI, PTCA, CABG, Positive TMT or Angiographic Evidence of Coronary Heart Disease.
Specify Here: / ……………………………………………………………..
Exclusion Criteria :
1. Patients with serious unrelated disease [e.g. advanced malignancy, surgery or trauma]which may limit life expectancy to less than the 30-day follow up period
2. Patient brought dead on arrival at hospital
Patient Participating in any other clinical trial?* / No
Yes / Specify Here : ………………………………
- Medical History & Risk Factors
Not Known / No / Yes
Stable Angina* / / /
Prior MI* / / / / If Yes / …………… / (if > 1 Episode, Give Year of the most recent one)
PTCA* / / /
CABG* / / /
- Medical History & Risk Factors (Contd.)
Not Known / No / Yes
Positive TMT* / / /
CAG Evidence of CAD* / / /
Other Cardiovascular Events* / / / / If Yes / TIA/Stroke / Peripheral Artery Disease
/ Renovascular Disease / CHF
/ Any Other Vascular Disease
Family History
of CHD / Stroke* / / /
Dyslipidemia* / / /
Hypertension* / / / / If Yes / Less than 1 Yr
/ 1 or more Yrs / Duration (Yrs) : ………………
Diabetes* / / / / If Yes / Less than 1 Yr
/ 1 or more Yrs / Duration (Yrs) : ………………
Smoking Status* / Never
/ Yes / Current Smoker / Smoking Since : ………….Yrs ………….Months;
Number : ………….Per Day
/ Past Status / Smoked For : …………. Yrs …………. Months ;
Left Since : ………….Yrs ………….Months
Smokeless Tobacco Status [Paan with tobacco,Gutka Etc.]* / Never
Yes / Current Status / Taking Since : ………….Yrs ………….Months ;
Number : ………….Per Day
/ Past Status / Took For: ………….Yrs ………….Months;
Left Since : ………….Yrs ………….Months
- Presentation
Symptom Onset *: / ……/……/………… (DD/MM/YY) …... : …… (24 Hour Clock)
First Contact With Medical Professional*: / ……/……/………… (DD/MM/YY) …... : …… (24 Hour Clock)
a. First Medical Contact / Registry Hospital
Other (e.g. General Physician, Nursing Home etc)
If Other please specify: ………………………………………….
b. Time lapsed after symptom onset to first medical contact: ……………………….
c. If time lapse is more than 6 Hrs, Reasons for delay: ………………………..
/ Patient did not recognize symptoms
/ Confused with gastritis/acidity
/ Long travel time
/ Lack of transportation
/ Event occured at odd hours
/ Went to alternate systems of medicine
/ Financial reasons
/ Others Specify Here: ……………………
d. Whether patient admitted at first medical contact health facility: / No Yes
If Yes: Dischaged Referred
e. Whether ECG done at FMC Health Facility: No Yes
If Yes: Suspected STEMI Suspected NSTEMI/UA
f. Treatment given at first medical contact facility: / Aspirin / Clopidogrel
Thrombolytic Therapy / Statin
None
g. Medical records for item d & f available? : No Yes
Mode of Transport to First Medical ContactFacility *:
(Select One) / Ambulance
Private Transport e.g. Car
Public Transport e.g. Bus
Other / Specify : …………………………………
Mode of Transport to Registry Hospital*:
(Select One)
/ Ambulance
Private Transport e.g. Car
Public Transport e.g. Bus
Other / Specify : …………………………………
Transfer From Other Hospital* / No
/ Yes / If Yes / Name of The Hospital : …………………………………..
Date/Time / ……/……/………… …... : ……
(DD/MM/YY) (24 Hour Clock)
Documentation Available? / No / Yes
Presentation to Emergency Room/Casuality*: / ……/……/………… (DD/MM/YY) …... : …… (24 Hour Clock)
- Provisional Diagnosis
PROVISIONAL DIAGNOSIS ON ADMISSION*: / Unstable Angina
(Select Any One) / ST Elevation
MI
Non ST Elevation MI
Rule Out MI/ACE
Other Cardiac
Other
- Physical Examination at Time of Presentation
Heart Rate(per minute) *: ……………….. / Blood Pressure (Systolic): …………………. / Blood Pressure (Diastolic): ………………….
Kilip Class*: / I (No CHF) / II(Rales)
/ III (Pulmonary Edema) / IV (Cardiogenic Shock)
- ECG Findings
1a. Index ECG in Registry Hospital / ……/……/………… (DD/MM/YY) …... : …… (24 Hour Clock)
1b. ECG System of the heart / STEMI / ST elevation
Anterior leads
Lateral leads
Inferior leads
Septal leads
/ NTEMI / USA / ST depression
T waves
/ None
Left Bundle Branch Block* / No
/ Yes If Yes / New / Old / Unknown
Right Bundle Branch Block* / No
/ Yes If Yes / New / Old / Unknown
1c. Other abnormalities ? (Fill in all that apply) * / No
/ Yes / If Yes
/ Atrial Fib/Flutter
/ Vtach
/ Posterior Infarction
/ RBBB
/ Nonspecific ST/T Change
/ Paced Rhythm
/ Left Ventricular Hypertrophy
/ AV Block (mobitz,3) →
/ First Degree
Type I 2nd Degree
Type II 2nd Degree
3rd Degree
- Laboratory
Initial Creatinine* / No
/ Yes / µmol/liter …………………………………
mg/dl …………………………………
Random Glucose* / No
/ Yes / µmol/liter …………………………………
mg/dl …………………………………
Fasting Glucose* / No
Yes / µmol/liter …………………………………
mg/dl …………………………………
Cardiac Marker - Maximum Values in 1st 24 hrs
CPK* / Not Done
Done / Qualitative / +ve / -ve
Quantitative / ……………………….. / ULN : ………………..
CK-MB* / Not Done
Done / Qualitative / +ve / -ve
Quantitative / ……………………….. / ULN : ………………..
Troponin* / Not Done
Done / Trop I / Qualitative / +ve / -ve
Trop T / Quantitative / ……………………….. / ULN : ………………..
- Hospital Treatment Counselling (Fill in all that apply)
Pre-Hospital Management* / Aspirin
Statins
Others Select From List
None / Clopidogrel / Prasugrel / Ticagretor
Unfractionated Heparin
LMWH & Fondaparinux
Oral Anticoagulants
Glycoprotein II B/ III A Inhibitors
Nitrates
Trimetazidine
Ranolazine
Beta-Blockers
Calcium Channel Blockers
a)Non-Dihydropyridine
b)Dihydropyridine
ACE Inhibitors
ARBs
Fibrates
Insulin
Other Antidiabetics
None of These
During Admission* / Aspirin / Calcium Channel Blockers:
Clopidogrel / Prasugrel / Ticagretor / a)Non-Dihydropyridine
Unfractionated Heparin / b)Dihydropyridine
LMWH & Fondaparinux / ARBs
Glycoprotein II B/III A Inhibitors / Statins
Nitrates / Fibrates
Beta-Blockers / Insulin
ACE Inhibitors / Other Antidiabetics
None
Prescribed at Discharge* / Aspirin / Calcium Channel Blockers:
Clopidogrel / Prasugrel / Ticagretor / a)Non-Dihydropyridine
Oral Anticoagulants / b)Dihydropyridine
Nitrates / ARBs
Trimetazidine / Statins
Ranolazine / Fibrates
Beta-Blockers / Insulin
ACE Inhibitors / Other Antidiabetics
None
- Revascularization Therapy
Did the Patient undergo following Treatment / Procedure during Hospitalization ?
Thrombolysis* / No / If No / Out of window period / Not Indicated
/ Eligible but no consent / Patient could not afford
/ Incomplete Treatment / Done before patient reached Reg Hospital
/ Underwent PTCA
/ Yes / If Yes / ……/……/………… (DD/MM/YY) …... : …… (24 Hour Clock)
Thrombolytic Agents / Streptokinase / Urokinase
Tenecteplase / RTPA
ECHO* / No
/ Yes / If Yes / LVEF Ejection Fraction % / Value : ………………...
RWMA / Yes / No
Angiography* / No / If No / Not Indicated / Eligible but no consent
/ Hospital does not have facility / Patient could not afford
/ Planned later / Not available during emergency working hours
/ Yes / If Yes / ……/……/………… (DD/MM/YY) …... : …… (24 Hour Clock)
Left Main Disease >=50% / Yes / No
Number Diseased Vessels with ≥50% Stenosis / 0 / 1 / 2 / 3
Culprit Vessel / LAD / Left Circumflex
Right Coronary / Left Main
Saphenous Vein Graft / LIMA/RADIAL Graft
PTCA* / No / If No / Not Indicated / Eligible but no consent
/ Hospital does not have facility / Patient could not afford
/ Not available during emergency working hours
/ Yes / If yes / ……/……/………… (DD/MM/YY) …... : …… (24 Hour Clock)
Stent Used? / No
/ Yes / If Yes / Drug Eluting Stent / Bare Metal Stent
/ Indigenous / FDA Approved
Glycoprotein II B/ III A Inhibitors Used No
Yes
Make of Stent / ………………………………
No of Stents / ………………………………
No of Vessels treated / ………………………………
CABG* / No / If No / Not Indicated / Eligible but no consent
/ Hospital does not have facility / Patient could not afford
/ Not available during emergency working hours
/ Yes / If yes / ……/……/………… (DD/MM/YY) …... : …… (24 Hour Clock)
- Events and Outcome in The Hospital
Reinfarction* / No
/ Yes / If Yes : / ……/……/………… (DD/MM/YY)
Stroke* / No
/ Yes / If Yes : / ……/……/………… (DD/MM/YY)
/ Hemorrhagic[CT/MRI Confirmed]
/ Ischemic[CT/MRI confirmed]
/ Unclassified [Only Clinical Diagnosis or Uncertain]
LV Failure* / No
/ Yes / If Yes : / ……/……/………… (DD/MM/YY)
Recurrent Ischemia/Angina* / No
/ Yes / If Yes : / ……/……/………… (DD/MM/YY)
Cardiac Arrest* / No
/ Yes / If Yes : / ……/……/………… (DD/MM/YY)
/ Ventricular Fibrillation
/ Pulseless VT
/ Asystole
/ Un-witnessed Arrest
Cardiogenic Shock* / No
/ Yes / If Yes : / ……/……/………… (DD/MM/YY)
Pulmonary Embolism* / No
/ Yes / If Yes : / ……/……/………… (DD/MM/YY)
Bleeding Requiring Transfusion* / No
/ Yes / If Yes : / ……/……/………… (DD/MM/YY)
Final Outcome*
Death / No
Yes / If Yes : / ……/……/………… (DD/MM/YY)
Cause: / Cardiovascular / Non-Cardiovascular
Discharge / No
Yes / If Yes : / ……/……/………… (DD/MM/YY)
Diagnosis at discharge*
Unstable Angina / No
Yes
MI / No
Yes / If Yes : / STEMI / NSTEMI
Location of MI: / AWMI / IWMI
/ IWMI + RVMI / Lateral Wall MI
Physical measurements at discharge
Height(cm) : / …………………………………………………….
Weight(kg) : / …………………………………………………….
BMI(kg/m2) : / Automaticlly Calculated [Please do not fill]
Payment Methods Adopted by ACS Patient? *
/ Completely by Patient
/ Partially by Patient and Partially by Insurance
/ Partially by Patient and Partially by Govt.
/ Partially by Patient and Partially by Employer
/ Completely by Insurance
/ Completely by Govt.
/ Completely by Employer
/ Charitable Hospital & Patient will get Free Care
- Counselling
Adviced to Quit Smoking* / No / Yes / Not Known
Dietary Modification Counseling* / No / Yes / Not Known
Exercise Counseling* / No / Yes / Not Known
Cardiac Rehab Referral* / No / Yes / Not Available
Lost to Follow-up / No / Yes / Specify Reasons / …………………………………………..
Follow-up / Hospital Visit / Home Visit / Telephone / Postal
Outcome / Alive
Death / If Dead: / ……/……/………… (DD/MM/YY) …... : …… (24 Hour Clock)
Cause: / Cardiovascular / Non-Cardiovascular
DRUGS PRESCRIBED AND TAKEN
Define Regularity (Adherence Rate)↓
Anti Platlet Agents / No
Yes / If Yes / Aspirin / < 50%
Cilostazol / 50 - 70%
/ Clopidogrel / 71 - 90 %
/ Prasugrel / > 90 %
Other
Oral antithrombotics / No
Yes / If Yes / Acitrom / < 50%
/ Warfarin / 50 - 70%
/ Other / 71 - 90 %
> 90 %
Beta Blockers / No
Yes / If Yes / Atenolol / < 50%
Carvedilol / 50 - 70%
Metoprolol / 71 - 90 %
Nebivolol / > 90 %
/ Propranolol
Other
ACE inhibitors / No
Yes / If Yes / Enalapril / < 50%
/ Lisinopril / 50 - 70%
Ramipril / 71 - 90 %
Other / > 90 %
FOLLOW UP ………………. (Contd.)
Calcium Channel Blockers / No
/ Yes / If Yes / Amlodipine / < 50%
Diltiazem / 50 - 70%
Verapamil / 71 - 90 %
Other / > 90 %
Angiotensin Receptor Antagonists / No
Yes / If Yes / Losartan / < 50%
Olmesartan / 50 - 70%
Telmisartan / 71 - 90 %
Other / > 90 %
Lipid Lowering Drugs / No
/ Yes / If Yes / Atorvastatin / < 50%
Fenofibrate / 50 - 70%
/ Rosuvastatin / 71 - 90 %
Simvastatin / > 90 %
Other
Other Cardiovascular Drugs / No
/ Yes / If Yes / A. NITRATES / < 50%
/ -- Nitrotryglcerine
--Isosorbide Mononitrate / 50 - 70%
/ B. NICORANDIL / 71 - 90 %
/ C. TRIMETAZIDINE / > 90 %
/ D. RANOLAZINE
E. DIURETICS
--Chlorthalidone
--Furosemide
-Hydrochlorothiazide
/ --Spironolactone
/ --Torsemide
/ F. OTHER
Insulin / No
Yes / If Yes / Regular Insulin / < 50%
/ Other / 50 - 70%
71 - 90 %
> 90 %
EVENTS AND PROCEDURES AFTER DISCHARGE UPTO ______FROM ADMISSION
Rehospitalization / No
Yes / If Yes / ……/……/………… (DD/MM/YY)
Reason / Worsening Angina
Heart Failure
FOLLOW UP ………………… (Contd.)
Reinfarction / No
/ Yes / If Yes / ……/……/………… (DD/MM/YY)
Stroke / No
/ Yes / If Yes / ……/……/………… (DD/MM/YY)
Cause / Hemorrhagic[CT/MRI Confirmed]
Ischemic[CT/MRI confirmed]
/ Unclassified [Only Clinical Diagnosis or Uncertain]
Cardiac Arrest / No
/ Yes / If Yes / ……/……/………… (DD/MM/YY)
Cause / Ventricular Fibrillation
/ Pulseless VT
/ Asystole
Coronary Angiography / No
/ Yes / If Yes / ……/……/………… (DD/MM/YY)
PTCA / No
/ Yes / If Yes / ……/……/………… (DD/MM/YY)
Reason / Recurrence of ACS
/ Worsening Angina
/ Inducible Ischemia on Stress
/ Any Other
Specify: ………………….
CABG Surgery / No
/ Yes / If Yes / ……/……/………… (DD/MM/YY)
Reason / Recurrence of ACS
/ Worsening Angina
/ Inducible Ischemia on Stress
/ Any Other
Specify: ………………….
Mandatory Field -> *; Radio Button (Select One)) -> Red; Drop down Menu (Select One) -> Blue; Check Box (Multiple Selection) -> Purple
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