Determination of drug therapy with percutaneous coronary intervention in the treatment of chronic stable angina
Design
Two arm parallel groups, not blinded, stratified randomization by gender, design of 100 patients (50 patients in each group).
Settings and conduct
Farshchian Cardiovascular Hospital, Hamedan
Records of patients with chronic stable angina include ECG, function class, echocardiography and angiographic information are collected. They are divided into two groups. Before the intervention, quality of life questionnaire and basic information are recorded. 6 months later, patients are visited and quality of life is assessed for clinical signs, emergency and hospitalization, FC, and ECG. Echocardiography is taken if there are clinical signs. These results are compared with the patient's initial results.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. More than 70% stenosis in at least one coronary artery
2. EF more than 30%
Exclusion criteria:
1. Resistant angina class IV
2. Treatment-resistant heart failure
3. Cardiogenic shock
4. Anatomy inappropriate for PCI
5. Chronic renal failure
6. Proximal LAD obstruction
7. Triple Vessel Disease
8. Diabetes, smoker
Intervention groups
Group 1: drug treatment of ischemic heart disease
Group 2: PCI treatment + drug treatment of ischemic heart disease
Main outcome variables
1. Quality of life: in terms of the patient's clinical symptoms and based on the chronic angina checklist
2. Go to the emergency room
3. Number of hospitalizations
4. Function Class : Angina classification based on the New York Heart Association.
5. Ejection fraction: The amount of left ventricular blood is expelled with each contraction.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211129053210N1
Registration date:2021-12-19, 1400/09/28
Registration timing:prospective
Last update:2021-12-19, 1400/09/28
Update count:0
Registration date
2021-12-19, 1400/09/28
Registrant information
Name
Mahsa Movahedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 8078
Email address
mahsa.movahedi@ymail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-20, 1400/10/30
Expected recruitment end date
2023-03-20, 1401/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of drug therapy with percutaneous coronary intervention in the treatment of chronic stable angina
Public title
Comparison of drug therapy with percutaneous coronary intervention
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
More than 70% stenosis in at least one coronary artery
EF more than 30%
Exclusion criteria:
Resistant angina class IV
Treatment-resistant heart failure
Cardiogenic shock
Anatomy inappropriate for PCI
Chronic renal failure
Proximal LAD obstruction
triple vessel disease
Diabetes, smoker
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
stratified randomization by gender: An equal number of men and women participate in each group. The samples will be determined by Permuted block randomization using the table of random numbers of Allocation Random software. In this 2-group trial, 2 blocks of 50, including 25 participants in the intervention group and 25 participants in the medical group are selected. Blocking and allocation sequencing for concealment will be done by the person not involved in the research.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Sciences ,Shahid Fahmideh St.
City
Hamadan
Province
Hamadan
Postal code
8176763746
Approval date
2021-11-27, 1400/09/06
Ethics committee reference number
IR.UMSHA.REC.1400.695
Health conditions studied
1
Description of health condition studied
Chronic Ischemic Heart Disease
ICD-10 code
I25.9
ICD-10 code description
Chronic ischemic heart disease, unspecified
Primary outcomes
1
Description
Quality of life: In terms of the patient's clinical symptoms and based on the chronic angina checklist
Timepoint
Measurement of quality of life at the beginning of the study and 6 months after the intervention
Method of measurement
Chronic angina checklist
Secondary outcomes
1
Description
Go to the emergency room based on the patient's statements
Timepoint
Evaluation of emergency department visit 6 months after the intervention
Method of measurement
Based on the patient's statements
2
Description
Number of hospitalizations based on hospitalization documents
Timepoint
Evaluation of the number of hospitalizations 6 months after the intervention
Method of measurement
Based on hospitalization documents
3
Description
Function Class: Angina classification based on the New York Heart Association
Timepoint
Evaluation of class function at the beginning of the study and 6 months after the intervention
Method of measurement
Based on the patient's statements and New York Heart Association
4
Description
Ejection fraction based on echocardiographic findings
Timepoint
Ejection fraction at the beginning of the study and 6 months after the intervention
Method of measurement
Based on the patient's echocardiographic evidence
Intervention groups
1
Description
Control group: Cardiac ischemia drugs
Category
Treatment - Drugs
2
Description
Intervention group: Cardiac ischemia drugs with percutaneous coronary intervention
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian Cardiovascular Hospital
Full name of responsible person
Mohammad Mehdi Monajjem
Street address
Shahid Fahmideh Street
City
Hamadan
Province
Hamadan
Postal code
6517839131
Phone
+98 81 3838 1740
Email
m.monajjem97@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Shahid Fahmideh Street
City
Hamadan
Province
Hamadan
Postal code
8176763746
Phone
+98 81 3838 0717
Email
fanavari@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mahsa Movahedi
Position
Student Research Committee, Hamadan University of Medical Sciences
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Unit 6, No. 405, Javadieh St.
City
Hamadan
Province
Hamadan
Postal code
8176763746
Phone
+98 81 3838 8078
Email
mahsa.movahedi@ymail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mohammad Mahdi Monajjem
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Unit 6, No. 405, Javadieh St.
City
Hamadan
Province
Hamadan
Postal code
8176763746
Phone
+98 81 3838 8078
Email
mahsa.movahedi@ymail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mahsa Movahedi
Position
medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Unit 6, No. 405, Javadieh St.
City
Hamadan
Province
Hamadan
Postal code
8176763746
Phone
+98 81 3838 8078
Email
mahsa.movahedi@ymail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Age, gender, ejection fraction, emergency department visit, number of hospitalizations, quality of life and function class .
Can be shared after unidentified people.
When the data will become available and for how long
Access period starts from 2022
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Provide appropriate treatment to patients with chronic stable angina