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Catheter directed thrombolysis versus anticoagulation only in patients with Intermediate-high risk pulmonary emboli-A randomized clinical trial

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History
# Registration date Revision Id
3 2021-12-10, 1400/09/19 208675
2 2021-08-08, 1400/05/17 194049
1 2019-01-27, 1397/11/07 76937
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  • Primary outcomes

    #1
    Right ventricular function
    Right ventricular diameter/left ventricular diameter ratio
    عملکرد بطن راست
    نسبت قطر بطن راست به بطن چپ
    72 hours and 3-month after intervention
    3-month after intervention
    72 ساعت و 3 ماه بعد از مداخله
    3 ماه بعد از مداخله
    #2
    Right ventricle Size
    empty
    سایز بطن راست
    empty
    72 hours and 3-month after intervention
    empty
    72 ساعت و 3 ماه بعد از مداخله
    empty
    Echocardiography
    empty
    اکوکاردیوگرافی
    empty
    #3
    Clinical deterioration
    empty
    بدتر شدن سیر بالینی
    empty
    72 hours after intervention
    empty
    72 ساعت بعد از مداخله
    empty
    questionnaire
    empty
    پرسشنامه
    empty

  • Secondary outcomes

    #1
    Functional class
    Minor bleeding
    توانایی عملکردی
    خونریزی مینور
    3-month after intervention
    Duration of hospitalization
    3 ماه بعد از مداخله
    طول مدت بستری
    Questionnaire
    Bleeding Academic Research Consortium scale
    پرسشنامه
    مقیاس Bleeding Academic Research Consortium
    #2
    Minor bleeding
    Major bleeding
    خونریزی مینور
    خونریزی ماژوز
    مقیاس Bleeding Academic Research Consortium
    مقیاس Bleeding Academic Research Consortium
    #3
    Major bleeding
    Right ventricular diameter/left ventricular diameter ratio
    خونریزی ماژوز
    نسبت قطر بطن راست به بطن چپ
    Duration of hospitalization
    72 hours after intervention
    طول مدت بستری
    72 ساعت بعد از مداخله
    Bleeding Academic Research Consortium scale
    Echocardiography
    مقیاس Bleeding Academic Research Consortium
    اکوکاردیوگرافی
    #4
    empty
    Right ventricular recovery
    empty
    بهبودی بطن راست
    empty
    3 months after intervention
    empty
    3 ماه بعد از مداخله
    empty
    Echocardiography
    empty
    اکوکاردیوگرافی

  • Recruitment centers

    #1
    Name of recruitment center - English: Rajaie Cardiovascular Medical and Research Center
    Name of recruitment center - Persian: مرکز قلب و عروق شهید رجایی
    Full name of responsible person - English: Parham Sadeghipour
    Full name of responsible person - Persian: پرهام صادقی پور
    Street address - English: Vali-Asr Ave
    Street address - Persian: خیابان ولیعصر، جنب پارک ملت
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 199691110
    Phone: +98 21 2392 2092
    Fax:
    Email: psadeghipour@hotmail.com
    Web page address:
    Name of recruitment center - English: Rajaie Cardiovascular Medical and Research Center
    Name of recruitment center - Persian: مرکز قلب و عروق شهید رجایی
    Full name of responsible person - English: Parham Sadeghipour
    Full name of responsible person - Persian: پرهام صادقی پور
    Street address - English: Vali-Asr Ave, Hashemi Rafsanjani Exp
    Street address - Persian: خیابان ولیعصر، بزرگراه هاشمی رفسنجانی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1995614331
    Phone: +98 21 2392 2092
    Fax:
    Email: psadeghipour@rhc.ac.ir
    Web page address:
    #2
    Name of recruitment center - English: Tehran Heart Center
    Name of recruitment center - Persian: مرکز قلب تهران
    Full name of responsible person - English: Yaser Jenab
    Full name of responsible person - Persian: یاسر جناب
    Street address - English: Kargar Ave
    Street address - Persian: خیابان کارگر
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1411713138
    Phone: +98 21 8802 9256
    Fax:
    Email: yasjenab@gmail.com
    Web page address:
    Name of recruitment center - English: Tehran Heart Center
    Name of recruitment center - Persian: مرکز قلب تهران
    Full name of responsible person - English: Yaser Jenab
    Full name of responsible person - Persian: یاسر جناب
    Street address - English: Jalal Al Ahmad & North Kargar cross
    Street address - Persian: تقاطع خیابان کارگر و جلال ال احمد
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1411713138
    Phone: +98 21 8802 9256
    Fax:
    Email: yasjenab@tums.ac.ir
    Web page address:

  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Rajaie Cardiovascular Medical and Research Center
    Name of organization / entity - Persian: مرکز قلب و عروق شهید رجایی
    Full name of responsible person - English: Feridoun Nouhi
    Full name of responsible person - Persian: فریدون نوحی
    Street address - English: Vali-Asr Ave
    Street address - Persian: خیابان ولی عصر، جنب پارک ملت
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 199691110
    Phone: +98 21 2392 2020
    Fax:
    Email: fnoohi@yahoo.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Rajaie Cardiovascular Medical and Research Center
    Name of organization / entity - Persian: مرکز قلب و عروق شهید رجایی
    Full name of responsible person - English: Feridoun Nouhi
    Full name of responsible person - Persian: فریدون نوحی
    Street address - English: Vali-Asr Ave, Hashemi Rafsanjani Exp
    Street address - Persian: خیابان ولی عصر، بزرگراه هاشمی رفسنجانی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1995614331
    Phone: +98 21 2392 2020
    Fax:
    Email: fnoohi@rhc.ac.ir
    Web page address:

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
Acronym
IRCT registration information
IRCT registration number: IRCT20181022041406N1
Registration date: 2019-01-27, 1397/11/07
Registration timing: registered_while_recruiting

Last update: 2021-08-15, 1400/05/24
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
empty
Actual recruitment end date
empty
Trial completion date
empty
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: 200
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
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