Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000833268p
Ethics application status
Not yet submitted
Date submitted
9/05/2018
Date registered
16/05/2018
Date last updated
16/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of residual disease on long term outcomes after coronary intervention
Scientific title
Efffect of residual syntax score and syntax revascularization index on long term cardiovascular outcomes after percutaneous coronary intervention
Secondary ID [1] 294850 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary heart disease 307791 0
Condition category
Condition code
Cardiovascular 306837 306837 0 0
Coronary heart disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Residual significant coronary artery disease after percutaneous coronary intervention (bloooan angioplasty and/or stent imlantation) will be measured by using predefined residual syntax score and syntax revascularization index.. After that the effect of these meausrements on cardiovascular outcomes will be observed for minimum 4 years after the last performed intervnetion
Intervention code [1] 301152 0
Diagnosis / Prognosis
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 305826 0
Total mortality, total mortality will be determined by examining medical and hospital records.
Timepoint [1] 305826 0
at the end of 4 years after the last PCI performed, due to it's a retroprospective study, definite visit dates could not be established
Primary outcome [2] 305827 0
Composite end point of cardiovascular mortality, non fatal myocardial infarction and non fatal stroke. This end point will be measured by using hospital records and telephone or face to face contact with patients or first degree relatives.
Timepoint [2] 305827 0
at the end of 4 years after the last PCI performed, due to it's a retroprospective study, definite visit dates could not be established
Secondary outcome [1] 346690 0
Repeat coronary revascularization. This includes any unplanned subsequent coronary intervention after the index procedure. it will be measured by examining health records, patients files and related documents. also if available telephone or face to face contact with patients or first degree relatives will be sought.
Timepoint [1] 346690 0
at the end of 4 years after the last PCI performed, due to it's a retroprospective study, definite visit dates could not be established
Secondary outcome [2] 346691 0
Hospitalization due to cardiovascular causes. This includes any hospitalization due to cardiovascular causes after the index procedure. If the reason for hospitalization is one of the components of primary composite end points then it will be classified under primary end point. . it will be measured by examining health records, patients files and related documents. also if available telephone or face to face contact with patients or first degree relatives will be sought.
Timepoint [2] 346691 0
at the end of 4 years after the last PCI performed, due to it's a retroprospective study, definite visit dates could not be established

Eligibility
Key inclusion criteria
1- Patients over 18 years of age
2- Patients undergone percutaneous coornary interventon due to suspected or definite coronary heart disease including acute coronary syndromes
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1- Patients with a history of coronary artery bypass surgery
2- Patienst who are decided to be treated by coronary artery bypass surgery after diagnostic angiography
3- Patients with moderate or severe valvular heart disease
4- Patients with severe left ventricular systolci dysfunction (i.e. left ventricular ejection fraction below 30%)
4- PAatients with sevevre comorbid ilnesses including active malignancies

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Annual incidence of total mortality after PCI was 5.9% in previous studies. Expected incidence in study population is % 2. with alpha value 0.05 and power 80% calculated sample size is 230.
t-test and chi-square test will be used to compare groups. Kaplan Meier estimates of survival will be used to analyze mortality rates. Cox proportional hazard ratio will be used to determine independent variables affecting primary outcomes.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/06/2018
Actual
Date of last participant enrolment
Anticipated
29/06/2018
Actual
Date of last data collection
Anticipated
31/12/2018
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment outside Australia
Country [1] 10387 0
Turkey
State/province [1] 10387 0
ISTANBUL

Funding & Sponsors
Funding source category [1] 299442 0
Self funded/Unfunded
Name [1] 299442 0
Mustafa Aytek Simsek
Country [1] 299442 0
Turkey
Primary sponsor type
Individual
Name
Mustafa Aytek Simsek
Address
Yeditepe universitesi hastanesi icerenkoy mahallesi hastane sokak no:4a 34752
atasehir-istanbul
Country
Turkey
Secondary sponsor category [1] 298733 0
None
Name [1] 298733 0
Address [1] 298733 0
Country [1] 298733 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 300340 0
Yeditepe Unversity Ethics Commitee
Ethics committee address [1] 300340 0
Evren sitesi icerenkoy mahallesi hastane sokak atasehir-istanbul 34752
Ethics committee country [1] 300340 0
Turkey
Date submitted for ethics approval [1] 300340 0
28/05/2018
Approval date [1] 300340 0
Ethics approval number [1] 300340 0

Summary
Brief summary
Patients with suspected or definite coronary heart disease and were planned to undergo percutaneous coronary intervention between january 2013 and december 2014 will be included in the study. Effect of residual syntax score and syntax revascularization index on cardiovascular outcomes will be studied.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 83354 0
Dr Mustafa Aytek Simsek
Address 83354 0
Yeditepe Unvesitesi Hastanesi Icerenkoy Mahallesi Hastane Sokak No:4A 34752
Atasehir-Istanbul
Country 83354 0
Turkey
Phone 83354 0
+902165784250
Fax 83354 0
Email 83354 0
mustafa.simsek@yeditepe.edu.tr
Contact person for public queries
Name 83355 0
Dr Mustafa Aytek Simsek
Address 83355 0
Yeditepe Unvesitesi Hastanesi Icerenkoy Mahallesi Hastane Sokak No:4A 34752
Atasehir-Istanbul
Country 83355 0
Turkey
Phone 83355 0
+902165784250
Fax 83355 0
Email 83355 0
mustafa.simsek@yeditepe.edu.tr
Contact person for scientific queries
Name 83356 0
Dr Mustafa Aytek Simsek
Address 83356 0
Yeditepe Unvesitesi Hastanesi Icerenkoy Mahallesi Hastane Sokak No:4A 34752
Atasehir-Istanbul
Country 83356 0
Turkey
Phone 83356 0
+902165784250
Fax 83356 0
Email 83356 0
mustafa.simsek@yeditepe.edu.tr

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.