A Survey to Assess Effects of the Covid-19 Pandemic on Symptomatology, Treatment and Medical Care for Cardiovascular Patients
Conditions: Cardiovascular Diseases, Heart Failure
Sponsor: Centro en Insuficiencia Cardiaca, Mexico

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PROTOCOL TITLE: 
 
SURVEY TO ASSESS THE EFFECTS OF THE COVID-19 PANDEMIC ON SYMPTOMATOLOGY, 
TREATMENT AND MEDICAL CARE FOR CARDIOVASCULAR PATIENTS 
 
 
Principal investigator 
 
Dr. Eduardo Julián José Roberto Chuquiure Valenzuela 
Heart failure Center 
National heart institute of Mexico 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
______________________________________ 
 
 
 
 
Responsible investigator:  
 
Dr. Eduardo Julián José Roberto Chuquiure Valenzuela 
Heart failure Center 
National heart institute of Mexico 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
______________________________________ 
 
SUB INVESTIGATORS 
 
Dr. Alan Fuentes-Mendoza 
 
 
 
 
 
 
 
 
 
 
Heart failure Center 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
_____________________________________ 
Dr. Emmanuel Tapia López  
 
 
 
 
 
 
 
 
 
Heart failure Center 
 
 
 
 
General  8 Hospital 
 
 
 
_____________________________________ 
 
Dr. Daniel García Romero 
 
 
 
 
 
 
 
 
 
Heart failure Center 
 
 
 
 
 
 
 
 
General Hospital of Mexico 
 
 
 
_____________________________________ 
 
 
 
 
 
 

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PROJECT SUMMARY 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
PROJECT OBJECTIVES: 
 
Primary: 
Secondary(s): 
 
 
 
 
 
 
Purpose 
 
Apply a survey to identify changes in 
symptoms, therapeutic scheme, medical 
care in cardiovascular patients. 
 
 
Overall goal 
 
Establish symptomatic, therapeutic, and 
medical care modifications in sick patients 
cardiovascular 
 
Specifics Objectives   
 
 
To determine the impact of changes on: 
• Functional Class 
• therapeutic conducting 
• Need for medical care 
• Clinical disturbances 
• 
Emotional distress 
In patients with cardiovascular (CV) conditions, most hospital admissions in the emergency 
room are caused by decompensation of the previous etiological condition(v.g. ischemic 
heart disease, heart failure etc.)  leads to an increase in hospital re-entry mortality, anxiety 
disorders and hospital costs. The objective of this research is to establish symptomatic, 
therapeutic, and behavioral modifications in patients cardiovascular patients 
 
Material and method 
This study will consist of lifting a survey through a designated questionnaire that will qualify 
dimensions: 
Symptomatology, 
Therapeutics 
and 
Medical 
Care. 
Patients 
with 
cardiovascular conditions will be included. consecutively, over 18 years of age, of both 
genders. The CV diagnosis, based on two groups 1) Ischemic Cardiopathy(CAD), for one 
or more history Myocardial infarction, Hemodynamic study with obstructive coronary artery 
injury, Coronary artery angioplasty with balloon and/or stenting and coronary 
revascularization surgery(CABG). 2) Heart failure  here are criteria of the European Society 
of Cardiology(ESC criteria):Clinical pattern, laboratories, and cardiac imaging.  We will 
conduct telephone interview (if permitted by the face-to-face health authority)in the initial 
phase consists of the Principal Investigator's Name Presentation, from the Heart Failure 
Center, your consent and settlement will be requested, we will proceed to read you the 
questions, at the end again the Investigator will be appointed with his phone number, 
thanks and conclusion wit quarterly and annual monitoring 

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Introduction 
 
 
Cardiovascular diseases severely impact public health services, as it generates high rates of 
patients, hospitalization and mortality, which directly impact survival, quality of life1,2. In 
Mexico, Verdejo and collaborators3 demonstrated that the cardiovascular conditions that 
most impact are: coronary ischemic disease (CAD), Heart Failure (HF), High Blood Pressure 
(HTA) and Atrial Fibrillation (AF). They felt that the economic impact produced is significantly 
high. 
 
The prevalence of cardiovascular disease is increasingly important, prevalence can be close 
to 28% in the population over the age of 401,2. In recent decades it has been observed that 
this prevalence tends to rise for every decade, ranking around 45-63% in all over-70s4. It causes 
high demand for medical care, admission to emergency departments and hospitalization. 1,2,4 
 
In the United States of America, the record of CAD mortality during the twentieth century and 
the first decade of the 21st century, I lead on any other pathology2,4. Despite all the medical, 
technological and financial efforts in countries such as Mexico, protocols have been created 
for the integral management and control of this pathology 5, CAD mortality is the highest in 
the last three decades and affects 33% of Mexico's population. 5 
 
On the other hand, HF, this pathology associated with the malfunction of the heart, which 
impairs the mechanism to maintain a continuous cardiac systemic infusion on a regular basis. 
Patients have an unfavorable prognosis when they have reached the symptomatic phase6,7. 
About 50% of patients diagnosed with Heart failure die in the first 4 years in clinical follow-up4, 
this figure is 90% when severe HF has been diagnosed7.  Characteristically, HF has an 
inadequate role in emptying and/or filling cardiac ventricular chambers leading to a 
circulatory deficit to meet the body's metabolic and energy demands8,9. Heart Failure shows 
a wide range of clinical presentations, ranging from the completely asymptomatic subject, to 
absolute physical disability in advanced stages, pulmonary edema and cardiogenic shock. 
Causing the disease to decline in quality of life, high economic impact on the individual, on 
family life and in the health institutions responsible for the care of the population 7-9. Finally, 
with a significant reduction in life expectancy and high hospital mortality8.10. 
 
Drug treatment of HF has achieved, since over the decades, survival has improved, the rate 
of hospitalizations, such  as quality of life5,9 It is recognized that an HF patient  ingests 7 or more 
drugs a day which can complicate therapeutic follow-up such as adherence to them9-10. The 
therapeutic agents recognized in the treatment of HF  are: Angiotensin-converting enzyme 
inhibitors, (ACEI), angiotensin  receptor-blocking agents(ARB),beta blockers(BB), Diuretics, 
mineralocorticoid blockers,  and CV therapeutics anticoagulants, antiplatelet agents, Lipid 
lowering agents, antiarrhythmic, anti-ischemic, glucose-reducing agents. With this survey we 
aim to evaluate the modification of the use of such agents. 

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Since the end of 2019, there have been reports in Asia of the increase in the number of patients 
with Acute Respiratory Syndrome (ARDS)), subsequently,  it was associated that the causal 
agent is a variety of coronavirus recognizing the pathology mediated by this pathology with 
COVID-1911-13.  
 
COVID-19 infection causes direct and indirect myocardial effects. It is recognized that intra-
myocardia action there are viral   mechanisms associated with the tremendous activation of 
the immune system13. It is postulated, after the progression in replication and spread of the 
virus through blood circulation or the lymphatic    system, a  severe spread of myocytes 
coexists11,14. An extraordinary systemic inflammatory response could mediate a severe 
myocardial injury. Producing, focal or global inflammation of the myocardial, necrosis. This is 
clinically translated  as ventricular dysfunction and tachyarrhythmias, chest pain associated 
with changes in the electrocardiogram and abnormalities in wall motility 12-14. Acute 
myocardial dysfunction (especially in cardiovascular patients) may be associated with a 
severe inflammatory or toxic response of COVID-1911-14 
  
 
 
Justification 
 
Patients with CV and HF pathology have a high risk of morbidity and mortality from any 
bacterial or viral infection. In the context of the coVID-19 joint we consider that this group of 
patients are at risk compared to the population free of CV pathologies. That is why,  we 
consider the need to evaluate during the period of highest elevation of the pandemic through 
dimensions: Symptomatology, Therapeutics and Health Care. survey, with the aim of observing 
significant changes. Which will be compared in other time periods. 
 
 
Purpose 
 
Apply a survey to identify changes in symptoms, therapeutic scheme, and medical care in 
cardiovascular patients. 
 
 
 
Research question 
 
Will there be symptomatic, therapeutic, and medical care modifications in cardiovascular 
patients during the COVID-19 pandemic? 
 
 
Principal outcome 
 
Establish symptomatic, therapeutic, and medical care modifications in cardiovascular 
patients. 

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Targets  specifics 
 
To determine the impact of changes on: 
• 
Functional class 
• 
Therapeutic behavior 
• 
Need for medical care 
• 
Clinical disturbances 
• 
Emotional distress 
 
Scope of research 
 
Publication in scientific journal 
 
Variables 
• 
Symptomatology 
• 
Medical care 
• 
Therapeutic 
 
Conceptual definition 
 
Symptomatology 
 
The questionnaire has specific clinical questions, simple to answer, which aim to place the 
clinical conditions of the sick. Likewise, the functional classification of the New York Heart 
Association (NYHA) is a valid instrument for patients carrying cardiovascular pathologies, 
especially for CAD and HF, practical and easy to use. Through four degrees. Regarding the 
clinical interrogation where the location of each patient in that construct will be determined. 
 
 
Medical Care 
 
Determined by the need for each patient  to seek medical advice. It will be quantified in: 
medical care, and in the emergency department by decompensation and hospitalization by 
decompensation. 
 
 
Therapeutic 
Recording of any change or modification in the previously indicated therapist. 
 
 
 
 

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Operational definition 
 
VARIABLES  
(SIGNS) 
OPERATIONAL DEFINITION 
 
SCALE 
SOURCE 
Angina 
Diffuse, oppressive pain 
in the chest which may 
radiate to the upper left 
limb, jaw, and 
epigastrium. 
Class I (great efforts) 
Class II (Slight limitation of 
normal activity) 
Class III (Moderation of 
Regular Activity)  
Class IV (Any effort generates 
angina) 
Survey/File 
Myocardial 
infarction 
Acute Coronary 
Ischemic 
Syndrome 
Set of pathologies 
involving an inadequate 
contribution of O2  to the 
myocardium, generating 
an ischemic process. 
With ST segment elevation, 
No ST segment elevation, 
Unstable Angina 
Survey/File 
Edema 
Quantification of swollen 
ankles in both pelvic 
limbs 
Presence or absence 
Survey/File 
Health status 
 
 
Assessment of the 
condition of degree of 
improvement-worsening 
of your cardiovascular 
disease by individual 
consideration of each 
patient. 
It is valued in two dimensions: 
-Likert scale and 
visual analog _scale 
 
Survey/File 
Mortality 
Absence of vital signs 
and hospital death 
statement. 
Dichotomous: Presence or 
absence 
 
Survey/File 
Physical limitation Reduced ability to do 
simple daily activities: 
walking, running, doing 
work at home, bathing, 
or self-dressing 
 
Dichotomous: Presence or 
absence 
 
Survey/File 
Dyspnea 
New event or increased 
feeling of shortness of 
breath from minimal to 
great efforts. 
Dichotomous: Presence or 
absence 
 
Survey/File 
Orthopnea 
Decubitus dyspnea 
and/or increased use of 
two or more pillows. 
Dichotomous: Presence or 
absence 
 
Survey/File 

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VARIABLES  
(SIGNS) 
OPERATIONAL DEFINITION 
 
SCALE 
SOURCE 
 Paroxysmal 
nocturnal 
dyspnea 
Dyspnea that suddenly 
occurs to decubitus. 
 
Dichotomous: Presence or 
absence 
 
Survey/File 
Medical care 
Need to seek medical 
advice. 
Remote presence or not 
Survey/File 
Emergency room 
admission 
Medical intervention in 
emergency room by 
decompensation  or 
need to go to 
emergency medical 
service 
Dichotomous: Presence or 
absence 
 
Survey/File 
Hospitalization 
Hospital care for 
worsening or disease 
decompensation that 
warrants hospitalization 
 
It is valued in five dimensions: 
-Heart failure,  
-Another heart cause,  
-Another non-cardiac cause,  
-COVID,  
-None 
Survey/File 
Cardiovascular 
therapeutic  
modification 
Changes in the 
previously established 
therapeutic scheme. 
 
Dichotomous:  Presence or 
absence 
 
Survey/File 
Emotional distress 
Assessment of the 
condition of excessive 
and continuous level of 
concern and fear in 
everyday situations. 
 
It is valued in two dimensions: 
-Likert Scale and 
-Visual analog Scale 
 
Survey/File 
NYHA CLASS 
Functional classification 
of the New York Heart 
Association of the 
functional fitness of cv 
sufferers 
 
Inconveniences to: 
1 unchanged 
2. To great efforts 
3. Moderate efforts 
4. Minimal effort 
Survey/File 
 
 
Hypothesis 
Ho: There will be no clinical changes in cardiovascular disease. 
H1: There will be clinical changes in cardiovascular disease 
 
Design 
 
Case survey. Basal sample (June 2020) with three quarterly follow-ups (October 2020, February. 
2021 and June 202I). Non interventional. Nested in a cohort 

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Sample 
For the calculation of the sample size we declare an alpha error of 0.05, the power of the 
association of 20% and a change difference of 21%, thus we determined 70 patients per 
group, with 10% for losses. Our sample consists of a total of 140 subjects. 
 
Sampling 
Non-probabilistic- consecutive 
 
Inclusion criteria 
 
1. Over 18 years of age. 
2. Both genders. 
3. Patients  able to interact with the medium, understand and  answer the questioning. 
4.Defined History of Ischemic heart disease ( one or more criteria):  
• History of myocardial Infarction,  
• History of coronary obstructions,  
• 
History PTCA or stent  procedures 
• 
History of myocardial revascularization surgery. ( any diagnostic criteria) 
or 
5. Clinical diagnostic criteria for Heart Failure: 
• Signs and symptoms on the physical exam. 
• Laboratories: NTP-proBNP: >125pg/ml. and/or BNP: >35pg/ml. 
• Left ventricle ejection fraction (LVEF) <40% through any imaging method: Ultrasound, 
MRI, computed axial tomography and nuclear medicine.  
6. Accept and settlement to participate in the survey 
 
Exclusion criteria 
 
1. 
Impairment to contact patients. 
2. 
Physical and cognitive impairment that prevents optimal interrogation. 
3. 
Cultural barriers involving limitation of communication (languages, dialects, reading 
and writing, etc.). 
4. 
Not wish to participate. 
Procedures 
 
Development of research processes: 
 
 
1. It will consist of the phone search for cardiovascular disease. The initial process is the full-
name identification of the researcher, Reason for the call is to conduct the survey. 
2. We proceed to read the paragraph settlement. 
3. In case of acceptance: 

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4. It will read question by question, detailing doubts for a correct obtaining of answers, 
without involving with the nature of what is settled by the patient. 
5. At the end of the farewell, the main investigator's phones are appreciated and offered. 
6. With the possibility of conducting face-to-face interviews, when the authority deems 
them appropriate, we will proceed to invite patients to follow up, as well as, to sign the 
informed consent. 
7. Every three months the same survey will be conducted to determine the impact of any 
movement caused by the temporality. 
8. At the same time, the database will be automatically populated, which will be moved 
to the STATA system for the respective analysis. 
9. Data mining will be carried out. 
10. Followed by the statistical process. 
11. Development and writing of the document for publication. 
12. Send to scientific journal. 
13. Publication 
Finally, reports will be followed up to the ethics and research committee. 
 
 
Data analysis 
 
A survey will be lifted through the electronic platform, that will determine a document in ASCII 
code, therefore we will perform the analysis of the data will be carried out by means 
computational statistical programs (STATA). 
 
Statistical Analysis 
 
Initially we will use a univariable approach, which will consist of determining the distribution, 
bias, and kurtosis of each variable, we declare Smirnoff test for normality test  
 
Demographic and baseline characteristics of the both groups were compared using the 
Student t test or Chi square test. Continuous variables were reported as means (standard 
deviation). Categorical variables were reported as numbers (percentage). The odds ratio 
(OR) with 95% confidence interval (CI95%) were calculated by Chi square test. We consider a 
two-sided p value below 0.05 to be statistically significant. Analyses were performed with 
STATA statistics software, version 8.0 (Stata Corp,College Station, TX, USA). 
 
 
 
 

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Ethical considerations 
 
Prior to the start of the survey, the researcher will read the first paragraph where the patient 
verbally manifests the settlement to participate in this investigation. For quarterly follow-ups in 
the same way the patient verbally manifests the settlement to continue participating in this 
investigation. 
In accordance with the provisions of the health authority, federal or local, the first possibility 
that a face-to-face visit could be brought will apply the format of informed consent, with the 
criteria of the official Mexican standard for informed consents (NOM-004-SSA3-2012). Patients    
will decide to continue their participation. 
All researchers state that : 
-The clinical notes and data collected during the intervention will be used exclusively for 
teaching purposes (clinical reports, clinical sessions), preparation of doctoral thesis, research, 
publication in sources of a scientific and professional nature. 
-We will use confidentially and ethically the material and/or information contained in each 
case. Removing personal identification of patients from any source of information.  
 
If necessary, the researchers may refer me to the emergency department of the National 
Institute of Cardiology. Doubts, questions, or emergencies related to the study will be 
contacted by Dr. Eduardo Chuquiure Valenzuela by phone: (56666566 0 5554017407) 
Funding / Financing 
For this study we declare no funding.  
 
Human Resources 
Principal investigator designed the protocol concept, performed statistics, correction, and 
correction of the same. 
Doctors Emmanuel Tapia López, Daniel García Romero were interns under the mentorship of 
Dr. Eduardo Chuquiure Valenzuela, currently performing the residency of Internal Medicine 
in the designated hospitals, they collaborate in clinical, research and analysis activities for 
the Heart failure Center, in this protocol they will help the telephone interviews and writing 
the manuscript. performed statistics, correction, and correction of the same. 
 
Dr. Alan Fuentes Mendoza was a resident of clinical cardiology under the mentorship of Dr. 
Eduardo Chuquiure Valenzuela, currently performing work as a clinical cardiologist at the 
designated hospital: He collaborates in clinical, research and analysis activities for Heart 
failure Center, protocol will assist in telephone interviews and writing of the manuscript. 
performed statistics, correction, and correction of the same. 
Elyz Cortez and Alejandra Marin are interns in social service under the tutelage of Dr. Eduardo 
Chuquiure Valenzuela. 
 
Dr. Laura Rodríguez Chávez, Dr. Nilda Espíndola Zavaleta, Dr. Gerardo Vieyra Herrera, Dr. 
Enrique Lopez Mora , are affiliated cardiologists, who participate in the revision of the writing 
for publication. 

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REFERENCES 
 
1. Anderson e al. ACC/AHA Cost/Value Methodology in Guidelines and Performance 
Measures. Vol 63. No. 21, 2014:2304-22 
2. Braundwald. E Heart diseases A textbook cardiovascular medicine Elsevier, 2012 
3. Verdejo J.  et al Arch Cardiol Mex. 2018. https://doi.org/10.1016/j.acmx.2018.03.004 
4. Go AS, Mozaffarian D, Roger VL et al. Heart Disease and stroke statistics – 2014 Update A 
report from American Heart Association. Circulation 2014; 129: E28-E292. 
5. Martínez Ríos Marco. Infarto Agudo del miocardio Documento de postura. Editorial 
Intersistemas México.2014. 
6. Townsend N. Wickremasinghe K, Bhatnaga P et al. Coronary Heart Disease Statistics (2012 
Edition) 
London: 
British 
Heart 
Foundation, 
2012. 
Available 
from: 
http://www.bhf.org.uk/publication/view-publication .aspx?ps=1002097  
7. Guadalajara JF. Entendiendo la insuficiencia cardiaca. Archivos de Cardiología. 2006; 76: 
431-447. 
8. Cowie MR, Mosterd A, Wood DA, Deckers JW, Poole-Wilson  PA, Sutton GC, et al. The 
epidemiology of heart failure. Eur Heart J 1997; 18:208-25. 
9. Ponikowski P, Voors A, Anker S et al. 2016 ESC Guidelines for the diagnosis and treatment of 
acute 
and 
chronic 
heart 
failure. 
European 
Heart 
Journal 
2016. 
Doi:10.1093/eurheartj/ehw128 
10. Hawkins NM, Jhund PS, McMurray JJ et al. Heart Failure and socioeconomic status: 
accumulating evidence of inequality. Eur J Heart Fail 2012; 14:138-46. 
11. Yu CM, Wong R, Wu E, et al. Cardiovascular  complications of severe acute respiratory 
syndrome. Postgrad Med J. 2006;82(964):140-144. doi:10.1136/pgmj.2005.037515. 
12. Yang X, Yu Y, Xu J, et al. Clinical course, and outcomes of critically ill patients with SARS-
CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. 
Lancet Respir Med. Published online February 24, 2020. doi:10.1016/S2213-2600(20)30079-5 
13. Inciardi R, Lupi L, Zaccone G, Italia L,  Raffo M, Tomasoni D et al., Cardiac Involvement in a 
Patient 
with 
Coronavirus 
Disease 
2019 
(COVID-19). 
JAMA 
Cardiol. 
doi:10.1001/jamacardio.2020.1096 
14. Sociedad Española de Cardiología. Implicaciones de la pandemia por COVID-19 para el 
paciente con insuficiencia cardiaca, trasplante cardiaco y asistencia ventricular. 
Recomendaciones de la Asociación de Insuficiencia Cardiaca de la Sociedad Española 
de 
Cardiología 
Retrieved 
June5th 
, 
2020 
from 
https://secardiologia.es/multimedia/directos-online/11481-implicaciones-de-covid-19-
para-el-paciente-con-insuficiencia-cardiaca-trasplante-cardiaco-y-asistencia-ventricular 
 
 
 
 
 

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DESIGN AND PROCEDURES 
 
 
J 
J 
J 
J 
J 
J 
 
 
 

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INFORMED CONSENT 
FOLLOW-UP PROGRAM FOR CARDIOVASCULAR PATIENTS (English traduction) 
 
Mexico City, date _____ /____/ _____ 
Patient Name  
_________________________________________________________________________________________ 
institutional registration_____________________ Date of birth__________________________________ 
I freely state that I have been informed (a) by the lead investigator, broadly, understandably 
and to full satisfaction, of the characteristics and objectives of the 
SURVEY TO ASSESS THE EFFECTS OF THE COVID-19 PANDEMIC ON SYMPTOMATOLOGY, 
TREATMENT AND MEDICAL CARE FOR CARDIOVASCULAR PATIENTS 
 
I authorize and consent to Dr. Eduardo Julián José Roberto Chuquiure Valenzuela to perform 
the procedure. Due to the circumstances of the pandemic by COVID-19 I acknowledge that 
previously my consent was by telephone, this one ratifies the follow-up. 
Under this understanding, I recognize that the lead researcher, explained to me the 
information detailed below, which contains, among other things, the nature of the procedure 
plan and the benefits I will be able to obtain from accessing the program. 
This program consists of: 
• Knowledge and management of your illness 
• Importance of adherence to treatment 
• Optimal medication management 
• Determine the standard of morbidities. 
• Recognize the pattern of clinical symptoms 
• Establish the pattern of clinical signs 
• Know the modalities of therapeutic schemes. 
 
1. I give my consent for me as a patient to provide information from my file. 
 2. I understand that my participation is extremely important. 

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3. I consent to the clinical notes and data collected during the intervention being used by the 
physicians responsible for teaching purposes (clinical reports, clinical sessions), elaboration of 
doctoral thesis, research, publication in scientific and professional sources. 
4. I understand that the physicians in charge are responsible for the confidential and ethical 
use of the material and/or information contained in each case. Removing personal 
identification of patients from any source of information. This will always respect the right to 
confidentiality of information. 
5. I understand that if necessary, those responsible may refer me to another health service as 
a patient. 
6. I understand that my consent to participation is voluntary, and that I may withdraw at any 
time and when I deem it necessary, not without first setting out my reasons. 
7. I understand that there is the possibility that the intervention program or the procedure will 
continue according to the proposed plan. 
8. I also understand that there are no identified risks or possible complications arising from this 
program. 
Any questions or emergencies related to the study contact the phone: (55) 732911. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
PATIENT'S NAME AND SIGNATURE 
 
 
 
 
 
 
RESPONSIBLE NAME AND MEDICAL SIGNATURE 
Date: ___________________ 
 
 
 
 
 
NAME AND SIGNATURE OF RESPONSIBLE FAMILY 
MEMBER 
Address: _______________________________________ 
Kinship: _____________________________________ 
Date: _________________________________________ 
 
 
 
 
 
NAME AND SIGNATURE OF WITNESS 1 
Address: _______________________________________ 
Kinship: _____________________________________ 
Date: 
 
 
 
 
NAME AND SIGNATURE OF WITNESS 2 
Address: _______________________________________ 
Kinship: _____________________________________ 
Date: 
 

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Activities Chronogram 
 
 
 
 
Gant´s diagram 
 
2020 
2021 
Activity 
Jun 
Jul 
Aug 
Sep 
Oct 
Nov Dec 
Jan 
Feb 
Mar Apr 
May 
Jun 
Jul 
Protocol 
design. 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Database 
design. 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Data 
collection. 
X 
 
 
 
X 
 
 
 
X 
 
 
 
X 
 
Preparation 
of theoretical 
framework. 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Data mining 
 
X 
 
 
 
X 
 
 
 
X 
 
 
 
X 
Participation 
in 
congresses. 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
Elaboration of 
research 
articles. 
 
X 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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QUESTIONARIE ( English traduction) 
Symptomatology, Treatment, Daily Activities and Emotional Distress for Cardiovascular 
patients Survey (STRATA) 
 
ITEM 
Text to read patients 
Answer 
Initial  
Dear participant, the principal investigator, 
Dr Eduardo Chuquiure Valenzuela from The 
National Institute of Cardiology Is studying 
patients with cardiovascular conditions. 
In this phone interview, we propose to ask 
some questions that will also be asked to 
other patients like you 
We just want to know your opinion about 
the current situation of your illness, the 
symptoms of medical care as your 
treatment. 
At any time, you can freely request the end 
of the survey. 
Researchers are committed to making all 
responses confidential, for scientific research 
only 
  
A) I Agree 
B) I decline 
 
 
 
 
 

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GENERAL 
ITEM 
Text to read patients 
Answer 
1 
Registry number 
 
 
2 
Names 
 
 
3  
First name 
 
 
4 
In the last four weeks?  
 
How your health status qualified?  
 
Where  1= worst and  10 Excellent 
from 1 to 10  
 
(Analog-visual 
scale) 
 
5 
In the last four weeks?  
 
Rated your health status perception 
a. Excellent 
b. Good 
c. No change 
d. Poor 
e. Worst 
6 
Optative 
Cause of death 
HEART FAILURE: Related to acute HF 
decompensation 
CARDIAC: Any cardiovascular condition except 
heart failure 
NON-CARDIAC Any causes for non- 
cardiovascular diseases. 
 
a.- Heart failure 
b.- Cardiac 
c.- Non-Cardiac 
d.-COVID-19 
e.- None 
7 
Optative 
Date of death 
Day, month, year 
 
  
 
 

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DAILY ACTIVITIES PERCEPTIONS 
 
ITEM 
Text to read patients 
Answer 
8A 
In the last four weeks? 
Please, mention if you a perceived limitation 
on : 
-Jogging 
 
a.- Yes 
b.- No 
 
8B 
In the last four weeks? 
Please, mention if you a perceived limitation 
on : 
-Carrying > 5Kg. 
 
a.- Yes 
b.- No 
 
8C 
In the last four weeks? 
Please, mention if you a perceived limitation 
on : 
-Walking more 1 hour 
 
a.- Yes 
b.- No 
 
8D 
In the last four weeks? 
Please, mention if you a perceived limitation 
on : 
- Housework duties  
 
a.- Yes 
b.- No 
8E 
In the last four weeks? 
Please, mention if you a perceived limitation 
on : 
- Regular work activities.  
 
a.- Yes 
b.- No 
 
8F 
In the last four weeks? 
Please, mention if you a perceived limitation 
on : 
-Climbing stairs ( two steps)  
 
a.- Yes 
b.- No 
8G 
In the last four weeks? 
Please, mention if you a perceived limitation 
on : 
- Walking more 500 meters 
 
a.- Yes 
b.- No 
 
8H 
In the last four weeks? 
Please, mention if you a perceived limitation 
on : 
-Showering yourself 
 
a.- Yes 
b.- No 
8I 
In the last four weeks? 
Please, mention if you a perceived limitation 
on : 
-Dressing yourself 
 
a.- Yes 
b.- No 
 
 
 
 
 
 
 

Survey to assess effects of covid-19 pandemic on symptomatology, treatment and medica care for 
cardiovascular patients June 04, 2020 version 1.0  
 
 
 
 
 
page 19 de 22 
SYMPTOMS PERCEPTIONS 
 
ITEM 
Text to read patients 
Answer 
9 
In the last four weeks? 
 
Did you perceive chest pain? (Ischemic 
related) 
 
a.- Yes 
b.- No 
 
 
10 
In the last four weeks? 
  
Did you perceive shortness of breath? 
 
a.- Yes 
b.- No 
 
11 
In the last four weeks? 
 
Did you have needed two or more pillows for 
shortness of breath? 
 
 
a.- Yes 
b.- No 
 
(dichotomous) 
12 
In the last four weeks?  
Have you been suddenly awakened by 
shortness of breath ? 
 
a.- Yes 
b.- No 
 
13 
In the last four weeks? 
 
Did you perceive ankle swelling? 
 
a.- Yes 
b.- No 
 
14 
In the last four weeks  
 
Did you need clinical/medical assistance? 
 
Mention one.  
    
   a.- None 
   b.- Distance 
   c.- Face to Face 
15 
In the last four weeks? 
 
Did you receive clinical assistance in 
emergency room (ER) for medical 
decompensation? Mention one. 
 a.- Heart Failure  
 b.- Other cardiac  
 c.- Non cardiac 
 d.- COVID-19  
 e.- None 
16 
In the last four weeks? 
 
Did you have hospitalized for medical 
decompensation? 
Mention one. 
 a.- Heart Failure  
 b.- Other cardiac  
 c.- Non cardiac 
 d.- COVID-19  
 e.- None 
 
 
 
 
 

Survey to assess effects of covid-19 pandemic on symptomatology, treatment and medica care for 
cardiovascular patients June 04, 2020 version 1.0  
 
 
 
 
 
page 20 de 22 
 
TREATMENT  
ITEM 
Text to read patients 
Answer 
17A 
In the last four weeks 
 Have you modified your MEDICAL treatment? 
-ACEI 
 
 
a.- Yes 
b.- No 
17B 
In the last four weeks 
 Have you modified your MEDICAL treatment? 
-ARB 
 
 
a.- Yes 
      b.- No 
17C 
In the last four weeks 
Have you modified your MEDICAL treatment? 
-BETABLOCKES 
 
 
a.- Yes 
      b.- No 
17D 
In the last four weeks,  
Have you modified your MEDICAL treatment? 
-DIURETICS 
 
 
a.- Yes 
      b.- No 
17E 
In the last four weeks 
Have you modified your MEDICAL treatment? 
-NITRATES 
 
 
a.- Yes 
      b.- No 
17F 
In the last four weeks 
 Have you modified your MEDICAL treatment? 
-SPIRONOLACTONE 
 
a.- Yes 
       b.- No 
17G 
In the last four weeks 
Have you modified your MEDICAL treatment? 
-ASPIRIN 
 
a.- Yes 
      b.- No 
17H 
In the last four weeks 
Have you modified your MEDICAL treatment? 
-LIPID LOWERING AGENTS 
 
a.- Yes 
      b.- No 
17I 
In the last four weeks 
 Have you modified your MEDICAL treatment? 
-HYPOGLUCEMICS 
 
a.- Yes 
      b.- No 
17J 
In the last four weeks 
 Have you modified your MEDICAL treatment? 
-ANTIARRHYTHMIC 
 
     a.- Yes 
     b.- No 
17K 
In the last four weeks 
 Have you modified your MEDICAL treatment? 
-OTHER 
 
     a.- Yes 
     b.- No 
 
 
 
 

Survey to assess effects of covid-19 pandemic on symptomatology, treatment and medica care for 
cardiovascular patients June 04, 2020 version 1.0  
 
 
 
 
 
page 21 de 22 
 
 
 
 
EMOTIONAL DISTRESS 
 
ITEM 
Text to read patients 
Answer 
18 
In the last four weeks 
How your EMOTIONAL DISTRESS perception 
qualifies ¿  
Where  1= worst and  10 Excellent 
 
from 1 to 10  
 
(Analog-visual 
scale) 
19 
In the last four weeks 
 
Did  you consider  that your emotional distress 
perception  was associated  with any of these 
limitations? 
 
   a.- Heart failure 
   b.- Familiar 
   c.- work 
   d.- COVID-19  
   e.- None 
 
 
 
 

Survey to assess effects of covid-19 pandemic on symptomatology, treatment and medica care for 
cardiovascular patients June 04, 2020 version 1.0  
 
 
 
 
 
page 22 de 22 
 
NYHA Functional class 
 
20 
Rate NYHA Functional class 
 
Question answered by the interviewer doctor 
 
a.- 1 
b.- 2 
c.- 3 
d.- 4 
 
 
 
CLOSING  
 
 
Closing We appreciate your participation. 
We'll be tracking it over the phone or when possible by 
face-to-face interview 
 
Any questions do not hesitate to contact Dr. Eduardo 
Chuquiure Valenzuela at 55732911 ext. 30021