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General information
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CANARY
CANARY
200
288
200288
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94
94
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2018-12-22, 1397/10/01
2018-12-22 00:00:00
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2020-02-02, 1398/11/13
2020-02-02 00:00:00
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2020-05-02, 1399/02/13
2020-05-02 00:00:00
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Adding the acronym, and the termination date
Adding the acronym, and the termination date
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اضافه کردن اکرونیم و تاریخ پایان مطالعه
اضافه کردن اکرونیم و تاریخ پایان مطالعه
Protocol summary
Study aim
To compare right venticular dysfunction, clinical deterioration, bleeding, mortality, functional class between catheter directed thrombolysis versus anticoagulation alone in patients with Intermediate- High Risk pulmonary emboli
Design
Randomized, parallel groups, with blinded outcome assessment controlled trial
Settings and conduct
The trial will be held in a hospital setting (Rajaie Cardiovascular Center and Tehran Heart Center) on patients with acute pulmonary emboli. Patients will be randomized via central web based method into intervention and control groups. Patients and physicians are not blinded. Echocardiographic indexes will be recorded on admission and 72 hours later. In follow up period, echocardiography exam and 6-minute walk test for functional class will be performed.
Participants/Inclusion and exclusion criteria
Inclusion:
Men and women ≥ 18 year-old, Acute pulmonary emboli must be confirmed with pulmonary CT angiography, Symptoms onset ≤ 14 days, Elevated pro b-type natriuretic peptide and cardiac troponin, Right ventricle/left ventricle ratio in pulmonary CT angiography >0.9
Exclusion:
Pulmonary emboli diagnosed with other modalities than pulmonary CT angiography, High risk (massive) pulmonary emboli, Severe renal dysfunction (creatinine clearance below 30 mL/min), Thrombolytic contraindication, Concomitant right heart thrombosis
Intervention groups
The intervention group will receive catheter directed thrombolysis. After femoral vein puncture, an infusion catheter will be inserted to the diseased pulmonary artery and thrombolytic will be started locally.
The control group will receive oral anticoagulation according to guideline
Main outcome variables
Primary outcome:
Right ventricular function; right ventricular size; in-hospital deterioration
Secondary outcome:
Mortality; functional class during follow up; Minor and Major Bleeding
General information
Reason for update
Adding the acronym, and the termination date
Acronym
CANARY
IRCT registration information
IRCT registration number:IRCT20181022041406N1
Registration date:2019-01-27, 1397/11/07
Registration timing:registered_while_recruiting
Last update:2021-12-10, 1400/09/19
Update count:2
Registration date
2019-01-27, 1397/11/07
Registrant information
Name
Parham Sadeghipour
Name of organization / entity
Rajaie Cardiovascular Medical and Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 2392 2092
Email address
psadeghipour@hotmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2021-12-22, 1400/10/01
Actual recruitment start date
2018-12-22, 1397/10/01
Actual recruitment end date
2020-02-02, 1398/11/13
Trial completion date
2020-05-02, 1399/02/13
Scientific title
Catheter directed thrombolysis versus anticoagulation only in patients with Intermediate-high risk pulmonary emboli-A randomized clinical trial
Public title
Thrombolysis via catheter in treatment of Pulmonary Emboli
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Men and women ≥ 18 year-old
Acute pulmonary emboli must be confirmed with pulmonary CT angiography
Symptoms onset ≤ 14 days
Elevated pro b-type natriuretic peptide and cardiac troponin
Right ventricle/left ventricle ratio in pulmonary CT angiography >0.9
simplified pulmonary embolism severity index score >=1
Less than 48 hours of anticoagulation therapy
Exclusion criteria:
Pulmonary emboli diagnosed with other modalities than pulmonary CT angiography
High risk (massive) pulmonary Emboli
Segmental pulmonary emboli
Patient with terminal illness
Surgery within 2 weeks
Severe renal dysfunction (creatinine clearance [CrCl] below 30 mL/min)
Platelet count <50.000
Thrombolytic contraindication
Concomitant right heart thrombosis
Pre and post catheter directed thrombolysis echocardiography exam not possible
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
288
Actual sample size reached:
94
Randomization (investigator's opinion)
Randomized
Randomization description
In the present study, concealment will be central via the website: http://thcresearch.net. After entering the username and password by the investigator, the patient ID will be asked by the web-based program. Then by using the permuted block randomization method, each patient (individual) will be assigned to intervention or control group.
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
Rajaie Cardiovascular Medical and Research Center Ethic committee
Street address
Vali-Asr ave, Hashemi Rafsanjani Exp
City
Tehran
Province
Tehran
Postal code
1995614331
Approval date
2018-11-14, 1397/08/23
Ethics committee reference number
IR.RHC.REC.1397.050
Health conditions studied
1
Description of health condition studied
Pulmonary emboli
ICD-10 code
I26
ICD-10 code description
Pulmonary embolism
Primary outcomes
1
Description
Right ventricular diameter/left ventricular diameter ratio
Timepoint
3-month after intervention
Method of measurement
Echocardiography
Secondary outcomes
1
Description
Mortality
Timepoint
During hospitalization and 3-months after intervention
Method of measurement
Questionnaire
2
Description
Minor bleeding
Timepoint
Duration of hospitalization
Method of measurement
Bleeding Academic Research Consortium scale
3
Description
Major bleeding
Timepoint
Duration of hospitalization
Method of measurement
Bleeding Academic Research Consortium scale
4
Description
Right ventricular diameter/left ventricular diameter ratio
Timepoint
72 hours after intervention
Method of measurement
Echocardiography
5
Description
Right ventricular recovery
Timepoint
3 months after intervention
Method of measurement
Echocardiography
Intervention groups
1
Description
Intervention group: The group will receive catheter directed thrombolysis. After femoral vein puncture, an infusion catheter will be inserted to the diseased pulmonary artery and thrombolytic will be started locally.
Category
Treatment - Drugs
2
Description
Control group: The group will receive oral anticoagulation according to guideline
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rajaie Cardiovascular Medical and Research Center
Full name of responsible person
Parham Sadeghipour
Street address
Vali-Asr Ave, Hashemi Rafsanjani Exp
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 2392 2092
Email
psadeghipour@rhc.ac.ir
2
Recruitment center
Name of recruitment center
Tehran Heart Center
Full name of responsible person
Yaser Jenab
Street address
Jalal Al Ahmad & North Kargar cross
City
Tehran
Province
Tehran
Postal code
1411713138
Phone
+98 21 8802 9256
Email
yasjenab@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rajaie Cardiovascular Medical and Research Center
Full name of responsible person
Feridoun Nouhi
Street address
Vali-Asr Ave, Hashemi Rafsanjani Exp
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 2392 2020
Email
fnoohi@rhc.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rajaie Cardiovascular Medical and Research Center
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
Rajaie Cardiovascular Medical and Research Center
Full name of responsible person
Parham Sadeghipour
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Vali-Asr Ave, Hashemi Rafsanjani Exp
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 2392 2092
Email
psadeghipour@rhc.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rajaie Cardiovascular Medical and Research Center
Full name of responsible person
Parham Sadeghipour
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Vali-Asr Ave, Hashemi Rafsanjani Exp
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 2392 2092
Email
psadeghipour@rhc.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Rajaie Cardiovascular Medical and Research Center
Full name of responsible person
Parham Sadeghipour
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Vali-Asr Ave, Hashemi Rafsanjani Exp
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 2392 2092
Email
psadeghipour@rhc.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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available