The aim of this study is to evaluate the effect of percutaneous coronary intervention (PCI) on diastolic function in patients with known coronary artery disease (CAD). 51 patients who have been candidates for PCI because of CAD; with left ventricular ejection fraction>30% and any degree of diastolic dysfunction (grade 1-4) and no left ventricular hypertrophy (LVH), uncontrolled hypertension (resting blood pressure>140/90 mm hg), Atrial fibrillation rhythm, hypertrophic cardiomyopathy, elevated Cr level, bundle branch or complete heart block, severe ventricular arrhythmias, severe valvular heart diseases, cardiac pacemakers and or prior coronary artery bypass graft surgery; preexamined by transthoracic echocardiography and diastolic indexes such as Isovolumic relaxation time (IVRT); Deceleration Time (DT); Transmitral flow velocity with atrial contraction duration/Flow from left atrium to pulmonary veins during atrial contraction duration (Mitral A duration/Pulmonary veins A duration); Early diastolic transmitral flow velocity/Velocity of early diastolic mitral annular motion(E/Ea); Pulmonary veins systolic flow/Pulmonary veins diastolic flow (PVs/PVd); Early diastolic transmitral flow velocity/Transmitral flow velocity with atrial contraction (E/A) were measured. Then patients underwent PCI. The diastolic indexes were reevaluated and recorded in forms three months after PCI and analyzed by statistic methods.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201111238182N1
Registration date:2011-12-01, 1390/09/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-12-01, 1390/09/10
Registrant information
Name
Sayyid Mokhtar Javdan Nezhad
Name of organization / entity
Kermanshah University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 83 1836 0295
Email address
sm.javdan@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences, Vice-chancellor for Research and technology
Expected recruitment start date
2011-11-16, 1390/08/25
Expected recruitment end date
2012-04-13, 1391/01/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative Survey of Left Ventricular Diastolic Function in CAD Patients Before and After PCI
Public title
The Efficacy Of percutaneous coronary intervention (PCI) on diastolic function in patients with coronary artery disease.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Pre PCI known CAD patients with any degree of diastolic dysfunction (grade 1 to 4) and LVEF>30% by echocardiography.
Exclusion criteria: left ventricular hypertrophy (LVH) , uncontrolled hypertension (resting blood pressure>140/90 mm hg), Atrial fibrillation rhythm, hypertrophic cardiomyopathy, elevated Cr level, bundle branch or complete heart block, severe ventricular arrhythmias, severe valvular heart diseases, cardiac pacemakers and prior coronary artery bypass graft surgery
Age
No age limit
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
51
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kermanshah university of medical sciences and health services
Street address
Shahid Beheshti blvd
City
Kermanshah
Postal code
Approval date
2011-11-12, 1390/08/21
Ethics committee reference number
40236
Health conditions studied
1
Description of health condition studied
Heart diastolic dysfunction
ICD-10 code
I30-I52
ICD-10 code description
Other forms of heart disease
Primary outcomes
1
Description
Grade of diastolic dysfunction
Timepoint
before and three months after PCI
Method of measurement
By echocardiography
2
Description
DT
Timepoint
Before and three months after PCI
Method of measurement
By echocardiography
3
Description
IVRT
Timepoint
Before and three months after PCI
Method of measurement
By echocardiography
4
Description
E/A
Timepoint
Before and three months after PCI
Method of measurement
By echocardiography
5
Description
Mitral A duration /PVa duration
Timepoint
Before and three months after PCI
Method of measurement
By echocardiography
6
Description
PVs/PVd
Timepoint
Before and three months after PCI
Method of measurement
By echocardiography
7
Description
E/Ea
Timepoint
Before and three months after PCI
Method of measurement
By echocardiography
Secondary outcomes
1
Description
LVEF
Timepoint
Before And Three months after PCI
Method of measurement
By echocardiography
Intervention groups
1
Description
Percutaneous coronary intervention
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali hospital
Full name of responsible person
Sayyid Mokhtar Javdan Nezhad
Street address
Imam Ali hospital, Shahid Beheshti blvd
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah university of medical sciences and health services
Full name of responsible person
Dr. Farid Najafi
Street address
Shahid beheshti blvd, Kermanshah university of medical sciences and health services
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kermanshah university of medical sciences and health services
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Kermanshah university of medical sciences and health services
Full name of responsible person
Sayyid Mokhtar Javdan Nezhad
Position
Cardiology resident
Other areas of specialty/work
Street address
Imam Ali hospital, Shahid Beheshti blvd
City
Kermanshah
Postal code
Phone
+98 83 1836 2022
Fax
+98 83 1836 2022
Email
sm.javdan@kums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah university of medical sciences and health services
Full name of responsible person
Nahid Salehi
Position
Echocardiologist
Other areas of specialty/work
Street address
Imam Ali hospital, Shahid Beheshti blvd
City
Kermanshah
Postal code
Phone
+98 83 1837 0252
Fax
+98 83 1836 2022
Email
N_salehi45@Yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah university of medical sciences and health services
Full name of responsible person
Sayyid Mokhtar Javdan Nezhad
Position
Cardiology resident
Other areas of specialty/work
Street address
Imam ali hospital, shahid beheshti blvd
City
Kermanshah
Postal code
Phone
Fax
+98 83 1836 2022
Email
sm.javdan@kums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)