Protocol summary

Study aim
evaluate the effect of Valsalva maneuver on ventricular systolic and diastolic functions, and measurement of NT-proBNP as a marker of heart failure
Design
patients will be enrolled in two groups: group 1: patients with mild coronary artery disease group 2: patients with severe coronary artery disease
Settings and conduct
Study will be conducted in 3 hospitals affiliated to Shiraz University of Medical Sciences:Faghihi Hospital, Nemazi hospital, and Alzahra Hospital. Serum NT-proBNP level of all patients measured at first 4 hours hospital admission period. Studies conducted during the second phase of Valsalva maneuver. Patients are blown on a narrow serum tube attached to the mercuric barometric device to 40 mm Hg pressure for 10 seconds. Systolic and diastolic indicators once before Valsalva and once during stage 2 of maneuver are measured
Participants/Inclusion and exclusion criteria
inclusion criteria:male or female, more than 18 years old, diagnosed with acute coronory syndrom, able to co-operate valsalva maneuver, unstable angina, STEMI, N-STEMI exclusion criteria: previous heart failure, history of several myocardial infarction, need emergency PCI or CABG, chronic respiratory distree or asthma,Persistent ischemia
Intervention groups
patients diagnosed with possible primary Acute Coronary Syndrome (ACS); unstable angina pectoris, STEMI and NSTEMI
Main outcome variables
The left atrium end-systolic volume ؛The left atrium volume index; The right atrium end-systolic area; The right ventricle end-systolic and -diastolic dimensions, The left ventricle (LV) ejection fraction; The peak flow velocity in early diastole (E-wave) and during the atrial contraction (A-wave) as well as the E/A ratio; Left and right ventricular systolic function; and serum NT-proBNP level willbe measured at first 4 hours hospital admission period in and its relation with echcardiographic changes will be studied

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20141218020364N11
Registration date: 2019-05-17, 1398/02/27
Registration timing: registered_while_recruiting

Last update: 2019-05-17, 1398/02/27
Update count: 0
Registration date
2019-05-17, 1398/02/27
Registrant information
Name
Mohhammad Yasin Karami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3839 1385
Email address
karamiy@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-14, 1398/02/24
Expected recruitment end date
2019-07-22, 1398/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Valsalva maneuver on echocardiographic findings in patients with ischemic heart disease
Public title
Effect of Valsalva maneuver on echocardiographic findings in patitents with cardiac disease
Purpose
Screening
Inclusion/Exclusion criteria
Inclusion criteria:
male or female patients more than 18 years old diagnosed with acute coronory syndrom able to co-operate valsalva maneuver able to understand or complete informed consent unstable angina, ST Segment Elevation Myocardial Infarction (STEMI), Non-ST Segment Elevation Myocardial Infarction
Exclusion criteria:
previous heart failure history of several myocardial infarction patients who needs emergency PCI or CABG patients with chronic respiratory distree or asthma patients with Persistent ischemia
Age
From 37 years old to 78 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 38
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
the participants are familiar with Valsalva manoveur method and echocardiography. the observer, who will complete the questionnaire, will not be familiar with the groups. the data analyzer will not know the study groups. However, the main researcher (cardiologist) had information about the groups, and all echocardiography will be performed by a different cardiologist.
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Zand sTreet
City
Shiraz
Province
Fars
Postal code
71348-14336
Approval date
2019-05-11, 1398/02/21
Ethics committee reference number
IR.SUMS.MED.REC.1398.135

Health conditions studied

1

Description of health condition studied
Acute Coronary Syndrome
ICD-10 code
I50
ICD-10 code description
Heart failure

Primary outcomes

1

Description
evaluation of the effect of Valsalva maneuver on ventricular systolic and diastolic functions
Timepoint
before and after maneuver
Method of measurement
assessment of echocardiographic indexes

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: patients with mild coronary artery disease
Category
Diagnosis

2

Description
Intervention group: patients with severe coronary artery disease
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
Department of Cardiology
Full name of responsible person
Mohammad Bagher Sharif kazemi
Street address
Zand
City
Shiraz
Province
Fars
Postal code
4815733971
Phone
+98 71 3612 5609
Email
msharifkazemi@hotmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Younes Ghasemi
Street address
Vice-chanceller of Research, Shiraz University of Medical Sciences Shiraz
City
Shiraz
Province
Fars
Postal code
98713451978
Phone
+98 71 3235 7282
Email
ghasemiy@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Mohhammad Yasin Karami
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Faghighi Hospital
City
Shiraz
Province
Fars
Postal code
4815733971
Phone
+98 71 3839 1385
Fax
+98 71 3233 0724
Email
karamiy@sums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohhammad Yasin Karami
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Faghighi Hospital
City
Shiraz
Province
Fars
Postal code
4815733971
Phone
+98 71 3839 1385
Fax
+98 71 3233 0724
Email
karamiy@sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohhammad Yasin Karami
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Faghighi Hospital
City
Shiraz
Province
Fars
Postal code
4815733971
Phone
+98 71 3839 1385
Fax
+98 71 3233 0724
Email
karamiy@sums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Loading...