Protocol - Myocardial Infarction

Description:

This measure assesses if an individual has had a myocardial infarction (MI) through collection of personal history of disease, treatment and procedure histories, and medical record abstraction.

Specific Instructions:

If the respondent answers "yes" to question 1 or question 2, the interviewer should complete the rest of the protocol. If the respondent answers "no" or "don't know," then the protocol is deemed complete.

Protocol:

1. Has a doctor ever told you that you had a myocardial infarction or heart attack?

[] 1 Yes

[] 0 No

[] 9 Don't Know

2. Have you had an outpatient or day surgery procedure to unblock blocked or narrowed blood vessels of the heart (called a PTCA, coronary angioplasty, stent, or atherectomy)?

[] 1 Yes

[] 0 No

Remainder of protocol to be abstracted from patient's hospital medical records.

3. Was there an acute episode of pain, discomfort or tightness in the chest, left arm or jaw within 72 hours of the hospitalization or within 72 hours of the in-hospital event?

[] Yes

[] No

[] Unknown

4. Was the discomfort or pain diagnosed as having a non-cardiac origin?

[] Yes

[] No

[] Unknown

5. Were electrocardiograms (ECGs or EKGs) recorded?

[] Yes

[] No

[] Unknown

If "No" or "Unknown," skip to 6.

Record dates of ECGs and make two copies of FOUR ECG tracings as described below. Send one copy to the ECG Reading Center and attach one copy to this form:

-- If four or fewer tracings were made, include all tracings.

-- If more than four tracings were made, include:

1. First two codable tracings after admission (ECG#1-First and ECG#2)

2. Last codable tracing prior to discharge or death (discharge tracing) (ECG-Last)

3. Last codable tracing on day 3 (or the first tracing thereafter) following an admission or in-hospital event (ECG#3)

4. The next codable tracing after day 3

-- If the participant is readmitted (transferred) to the ICU/CCU because of a new episode of chest pain, the first codable tracing may be sent.

Serum Enzymes

6. Were any cardiac enzyme measurements performed during this admission?

[] Yes

[] No

If "No," skip to end.

7. Did the participant have any active liver disease (cirrhosis, hepatitis, liver cancer, etc.)?

[] Yes

[] No

If "Yes," specify:

_____________________________________________________

8. Is there any evidence of hemolytic disease during this hospitalization?

[] Yes

[] No

9. Is there any mention of the participant having either trauma, a _ procedure, or rhabdomyolysis within one week prior to the measurement of the cardiac enzymes?

[] Yes

[] No

[] Unknown

If "Yes," please specify type of trauma or procedure below.

Date m/d/y: __ / __ / __ __

Type of Trauma or procedure:

__________________________________________

* Please complete ENZYME CHART. *

10. Myocardial infarction

[] Definite

[] Probable

[] No MI (skip to end)

If “Definite” or “Probable” enter date of MI (MM/DD/YYYY): __ __ / __ __ / __ __ __ __

Criteria

11. Chest Pain

[] Present

[] Absent

12. Cardiac Enzymes

[] Abnormal

[] Equivocal

[] Incomplete

[] Normal

13. ECG Serial Reading (pick one)

[] Evolution of Major Q-Wave

[] Evolution of ST-T Elevation with or without Q-Wave

[] New LBBB

[] Evolution of ST-Depression/Inversion alone

[] Evolution of Minor Q-Wave alone

[] Single ECG with Major Q-Wave

[] Single ECG with LBBB, described as new

[] Absent, Uncodable or Other ECG

14. Procedure-related:

[] Yes, cardiovascular

[] Yes, non-cardiovascular

[] No

Diagnostic Criteria:

Acute, Evolving or Recent MI

Either one of the following criteria satisfies the diagnosis for an acute, evolving or recent MI:

1. Typical rise and gradual fall (troponin) or more rapid rise and fall (CK-MB) of biochemical markers of myocardial necrosis with at least one of the following:

ischemic symptoms;
development of pathologic Q waves on the ECG;
ECG changes indicative of ischemia (ST segment elevation or depression); or
coronary artery intervention (e.g., coronary angioplasty).

2. Pathologic findings of an acute MI.

Established MI

Any one of the following criteria satisfies the diagnosis for established MI:

1. Development of new pathologic Q waves on serial ECGs. The patient may or may not remember previous symptoms. Biochemical markers of myocardial necrosis may have normalized, depending on the length of time that has passed since the infarct developed.

2. Pathologic findings of a healed or healing MI.

Protocol Name from Source:

The Expert Review Panel has not reviewed this measure yet.

Availability:

Publicly available

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Personnel and Training Required

An interviewer who is trained to conduct personal interviews with individuals from the general population is required to complete the protocols from the Cardiovascular Health Study (CHS) and the Women's Health Initiative (WHI). The interviewer must be trained and found to be competent (i.e., tested by an expert) at the completion of personal interviews.* The interviewer should be trained to prompt respondents further if a "don't know" response is provided.

*There are multiple modes to administer this question (e.g., paper-and-pencil and computer-assisted interviews).

A trained and certified Hospital Record Abstractor is required to complete the protocol from the Multi-Ethnic Study of Atherosclerosis (MESA). This person should be trained to perform medical record and chart abstraction using various hospital records.

Equipment Needs

None

Requirements

Requirement Category	Required
Major equipment	No
Specialized training	Yes
Specialized requirements for biospecimen collection	No
Average time of greater than 15 minutes in an unaffected individual	No

Mode of Administration

Interviewer-administered question, Medical record abstraction

Life Stage:

Adult

Participants:

Cardiovascular Health Study (CHS): >65 years old

Women's Health Initiative (WHI): women ages 50–79 years old*

Multi-Ethnic Study of Atherosclerosis (MESA): ages 45–85 years old

*While this questionnaire was used in a women's study, the Cardiovascular Working Group deems it appropriate to use with men.

Selection Rationale

A combination of four protocols was chosen to obtain sufficient data to assess whether a person had a myocardial infarction. Obtaining a personal history of myocardial infarction and treatment procedures, in combination with medical record abstraction, will provide a high level of specificity and reliability.

Language

English, Spanish

Standards

Standard	Name	ID	Source
Common Data Elements (CDE)	Person Myocardial Infarction Indicator	2935318	CDE Browser
Logical Observation Identifiers Names and Codes (LOINC)	Myocardial infarct proto	62397-5	LOINC

Derived Variables

None

Process and Review

The Expert Review Panel has not reviewed this measure yet.

Source

U.S. Department of Health and Human Services. National Institutes of Health. National Heart, Lung and Blood Institute. Cardiovascular haHealth Study (CHS). Baseline Medical History Questionnaire. Page 1. Question 1 (source for question 1).

U.S. Department of Health and Human Services. National Institutes of Health. National Heart, Lung and Blood Institute. Women's Health Initiative (WHI). Form 33D—Medical History Update. Version 4. Question 3.3 (source for question 2).

U.S. Department of Health and Human Services. National Institutes of Health. National Heart, Lung and Blood Institute. Multi-Ethnic Study of Atherosclerosis (MESA). Hospital Abstraction: Cardiac/Peripheral Vascular Disease (PVD) Form. Questions 15, 17, 27–31 (source for questions 3–9).

U.S. Department of Health and Human Services. National Institutes of Health. National Heart, Lung and Blood Institute. Multi-Ethnic Study of Atherosclerosis (MESA). Cardiac Review Form. Question 1 (source for questions 10–14 ).

Alpert, J. S., Thygesen, K., Antman, E., & Bassand, J. P. (2000). Myocardial infarction redefined—A consensus document of the Joint European Society of Cardiology/American College of Cardiology Committee for the redefinition of myocardial infarction. Journal of the American College of Cardiology, 36(3), 959–969 (source for Diagnostic Criteria).

General References

Ives, D. G., Fitzpatrick, A. L., Bild, D. E., Psaty, B. M., Kuller, L. H., Crowley, P. M., Cruise, R. G., & Theroux, S. (1995). Surveillance and ascertainment of cardiovascular events. The Cardiovascular Health Study. Annals of Epidemiology, 5, 278–285.

Psaty, B. M., Kuller, L. H., Bild, D., Burke, G. L., Kittner, S. J., Mittelmark, M., Price, T. R., Rautaharju, P. M., & Robbins, J. (1995). Methods of assessing prevalent cardiovascular disease in the Cardiovascular Health Study. Annals of Epidemiology, 5(4), 270–277.

Protocol ID:

40801

Variables:

Export Variables

Variable Name	Variable ID	Variable Description	Version	dbGaP Mapping
PX040801_Cardiac_Enzyme	PX040801120000	Cardiac Enzymes	4	N/A
PX040801_Chest_Discomfort	PX040801030000	Was there an acute episode of pain, discomfort or tightness in the chest, left arm or jaw within 72 hours of the hospitalization or within 72 hours of the in-hospital event?	4	N/A
PX040801_Chest_Discomfort_Non_Cardiac	PX040801040000	Was the discomfort or pain diagnosed as having a non-cardiac origin?	4	Variable Mapping
PX040801_Chest_Pain	PX040801110000	Chest Pain	4	N/A
PX040801_ECG_Serial_Reading	PX040801130000	ECG Serial Reading (pick one)	4	N/A
PX040801_Electrocardiogram	PX040801050000	Were electrocardiograms (ECGs or EKGs) recorded?	4	N/A
PX040801_Enzyme_Chart_Date	PX040801090700	Record all serum enzyme values Date (mm/dd/yy)	4	N/A
PX040801_Enzyme_Chart_Enzyme	PX040801090300	Record all serum enzyme values Serum enzyme	4	N/A
PX040801_Enzyme_Chart_Range	PX040801090400	Record all serum enzyme values Normal Range	4	N/A
PX040801_Enzyme_Chart_Time	PX040801090800	Record all serum enzyme values Time (hh:mm am/pm)	4	N/A
PX040801_Enzyme_Chart_Value_High	PX040801090600	Record all serum enzyme values Highest enzyme value	4	N/A
PX040801_Enzyme_Chart_Value_Low	PX040801090500	Record all serum enzyme values Lowest enzyme value	4	N/A
PX040801_Ever_Have_Myocardial_Infarction	PX040801010000	Has a doctor ever told you that you had a myocardial infarction or heart attack?	4	N/A
PX040801_Ever_Have_Stent	PX040801020000	Have you had an outpatient or day surgery procedure to unblock blocked or narrowed blood vessels of the heart (called a PTCA, coronary angioplasty, stent, or atherectomy)?	4	N/A
PX040801_Evidence_Hemolytic_Disease	PX040801080000	Is there any evidence of hemolytic disease during this hospitalization?	4	N/A
PX040801_Liver_Disease	PX040801070000	Did the participant have any active liver disease (cirrhosis, hepatitis, liver cancer, etc.)?	4	N/A
PX040801_Liver_Disease_Specify	PX040801070100	Did the participant have any active liver disease (cirrhosis, hepatitis, liver cancer, etc.)? If "Yes", specify.	4	N/A
PX040801_Myocardial_Infarction	PX040801100000	Myocardial infarction	4	N/A
PX040801_Myocardial_Infarction_Date	PX040801100100	Myocardial infarction: If "Definite" or "Probable" enter date of MI.	4	N/A
PX040801_Procedure_Related	PX040801140000	Procedure-related	4	N/A
PX040801_Serum_Enzyme	PX040801060000	Were any cardiac enzyme measurements performed during this admission?	4	N/A
PX040801_Trauma_Before_Enzyme_Measurement	PX040801090000	Is there any mention of the participant having either trauma, a surgical procedure, or rhabdomyolysis within one week prior to the measurement of the cardiac enzymes?	4	N/A
PX040801_Trauma_Before_Enzyme_Measurement_Date	PX040801090100	Is there any mention of the participant having either trauma, a surgical procedure, or rhabdomyolysis within one week prior to the measurement of the cardiac enzymes? If "Yes," specify date of trauma or procedure.	4	N/A
PX040801_Trauma_Before_Enzyme_Measurement_Type	PX040801090200	Is there any mention of the participant having either trauma, a surgical procedure, or rhabdomyolysis within one week prior to the measurement of the cardiac enzymes? If "Yes," specify type of trauma or procedure.	4	N/A

Cardiovascular

Measure Name:

Myocardial Infarction

Release Date:

September 9, 2009

Definition

Measure to assess if patient had a myocardial infarction (heart attack).

Purpose

Myocardial infarction (heart attack) is a leading cause of death for both men and women in the United States, which makes myocardial infarction a prevalent health issue for investigators to study.

Keywords

cardiovascular, myocardial infarction, heart attack, Multi-Ethnic Study of Atherosclerosis, MESA, Cardiovascular Health Study, CHS, Women's Health Initiative, WHI, chest pain, percutaneous transluminal coronary angioplasty, PTCA, coronary angioplasty, atherectomy, hospitalization, coronary stent, thrombolytic therapy, electrocardiogram, ECG, EKG, myocardial ischemia, ST-elevation myocardial infarction, STEMI, anticoagulation, coronary bypass surgery, personal history

Mapping for PX040801_Chest_Discomfort_Non_Cardiac

dbGAP Study	dbGAP Variable	dbGAP Variable Description
Atherosclerosis Risk in Communities (ARIC) Cohort	phv00203926	[Second transfer]. Non-cardiac source of chest pain. Q25e [Hospital Abstraction Form]
Atherosclerosis Risk in Communities (ARIC) Cohort	phv00203918	[Second transfer]. Was the discomfort or pain diagnosed as having a non-cardiac origin? Q25d [Hospital Abstraction Form]
Atherosclerosis Risk in Communities (ARIC) Cohort	phv00203781	Was the discomfort or pain diagnosed as having a non-cardiac origin? Q11d [Coroner / Medical Examiner Form]
DCCT-EDIC Clinical Trial and Follow-up of Persons with Type 1 Diabetes	phv00066214	C2. Non-cardiac cause for the pain
DCCT-EDIC Clinical Trial and Follow-up of Persons with Type 1 Diabetes	phv00051016	C2b. Non-cardiac cause for the pain
DCCT-EDIC Clinical Trial and Follow-up of Persons with Type 1 Diabetes	phv00051057	C2b. Non-cardiac cause for the pain
DCCT-EDIC Clinical Trial and Follow-up of Persons with Type 1 Diabetes	phv00048764	J2b2. Verification of event, chest pain: definite non-cardiac cause for pain
DCCT-EDIC Clinical Trial and Follow-up of Persons with Type 1 Diabetes	phv00049182	J2b2. Verification of event, chest pain: definite non-cardiac cause for pain
The Genomics and Randomized Trials Network (GARNET) Vitamin Intervention Stroke Prevention (VISP) trial	phv00168538	Was the discomfort or pain diagnosed as having a non-cardiac origin?
The Genomics and Randomized Trials Network (GARNET) Vitamin Intervention Stroke Prevention (VISP) trial	phv00179923	Was the discomfort or pain diagnosed as having a non-cardiac origin?

Protocol - Myocardial Infarction

Related Protocols:

Essential Protocols:

Description:

Specific Instructions:

Protocol:

Protocol Name from Source:

Availability:

Personnel and Training Required

Equipment Needs

Requirements

Mode of Administration

Life Stage:

Participants:

Selection Rationale

Language

Standards

Derived Variables

Process and Review

Source

General References

Protocol ID:

Variables:

Measure Name:

Release Date:

Definition

Purpose

Keywords