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Evaluation of Emotional Status and Coronary Flow Characteristics by TIMI Frame Count Method (STRAIN-TIMI)

Primary Purpose

Coronary Artery Disease, Coronary Artery Ectasia, Slow-Flow Phenomenon

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
coronary angiography
Sponsored by
Ertan YETKIN
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients whom planned elective coronary angiography and accept to be included in the study as a participant

Exclusion Criteria:

  • < 18 years, history of prior coronary angiography, history of coronary artery revascularization, acute coronary syndrome patients, atrial fibrillation, heart failure, known systemic diseases

Sites / Locations

  • Gulhane Military Medical AcademyRecruiting
  • Ankara Numune Training and Research HospitalRecruiting
  • Ankara Research and Training Hospital
  • Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
  • Private Gözde HospitalRecruiting
  • Private Yenisehir HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

normal coronary anatomy

coronary artery ectasia

slow coronary flow

nonobstructive coronary artery disease

obstructive coronary artery disease

Arm Description

coronary angiography will be performed by transfemoral or transradial route.

coronary angiography will be performed by transfemoral or transradial route.

coronary angiography will be performed by transfemoral or transradial route.

coronary angiography will be performed by transfemoral or transradial route.

coronary angiography will be performed by transfemoral or transradial route.

Outcomes

Primary Outcome Measures

TIMI frame count method analysis

Secondary Outcome Measures

Full Information

First Posted
July 10, 2016
Last Updated
July 10, 2016
Sponsor
Ertan YETKIN
Collaborators
Abant Izzet Baysal University, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi, Ankara City Hospital Bilkent, Private Yenisehir Hospital, Private Gozde Hospital, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02831153
Brief Title
Evaluation of Emotional Status and Coronary Flow Characteristics by TIMI Frame Count Method
Acronym
STRAIN-TIMI
Official Title
Effects of Emotional Status on Coronary Flow in Patients Undergoing Coronary Angiography:Multicenter TIMI Frame Count Assessment Study (STRAIN-TIMI Study)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (undefined)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
July 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ertan YETKIN
Collaborators
Abant Izzet Baysal University, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi, Ankara City Hospital Bilkent, Private Yenisehir Hospital, Private Gozde Hospital, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study evaluates the effects of emotional status on coronary flow in patients undergoing elective coronary angiography. Patients whom undergoing elective coronary angiography will fulfill the Beck Anxiety Inventory, Beck Depression Inventory, State-Trait Anxiety Inventory, Hospital Anxiety and Depression Scale. State Anxiety Inventory will be fulfilled both before the intervention and after 1 hour the patients learned the results of the coronary angiography. The other scales will be performed after 1 hour the patients learned their results. Coronary flow will be assessed by TIMI (Thrombolysis In Myocardial Infarction) frame count method.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Coronary Artery Ectasia, Slow-Flow Phenomenon, Endothelial Dysfunction, Anxiety, Depression

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
2000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
normal coronary anatomy
Arm Type
Active Comparator
Arm Description
coronary angiography will be performed by transfemoral or transradial route.
Arm Title
coronary artery ectasia
Arm Type
Active Comparator
Arm Description
coronary angiography will be performed by transfemoral or transradial route.
Arm Title
slow coronary flow
Arm Type
Active Comparator
Arm Description
coronary angiography will be performed by transfemoral or transradial route.
Arm Title
nonobstructive coronary artery disease
Arm Type
Active Comparator
Arm Description
coronary angiography will be performed by transfemoral or transradial route.
Arm Title
obstructive coronary artery disease
Arm Type
Active Comparator
Arm Description
coronary angiography will be performed by transfemoral or transradial route.
Intervention Type
Procedure
Intervention Name(s)
coronary angiography
Intervention Description
Coronary angiography will be performed by transfemoral or transradial approach in all patients. In order to evaluate each coronary artery, at least four views from the left and two views from the right system will be taken.
Primary Outcome Measure Information:
Title
TIMI frame count method analysis
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients whom planned elective coronary angiography and accept to be included in the study as a participant Exclusion Criteria: < 18 years, history of prior coronary angiography, history of coronary artery revascularization, acute coronary syndrome patients, atrial fibrillation, heart failure, known systemic diseases
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ertan Yetkin, MD
Phone
905327136721
Email
ertanyetkin@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Selcuk Ozturk, MD
Phone
905535376613
Email
selcukozturk85@hotmail.com
Facility Information:
Facility Name
Gulhane Military Medical Academy
City
Ankara
State/Province
Kecioren
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Turgay Celik, MD
Phone
905326731032
Email
benturgay@gmail.com
First Name & Middle Initial & Last Name & Degree
Turgay Celik, MD
Facility Name
Ankara Numune Training and Research Hospital
City
Ankara
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mehmet Ileri, MD
Email
maraspoli2020@gmail.com
First Name & Middle Initial & Last Name & Degree
Mehmet Ileri, MD
First Name & Middle Initial & Last Name & Degree
Hayriye Mihrimah Ozturk, MD
Facility Name
Ankara Research and Training Hospital
City
Ankara
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
City
Ankara
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Private Gözde Hospital
City
Malatya
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Izzet Tandogan, MD
First Name & Middle Initial & Last Name & Degree
Izzet Tandogan, MD
Facility Name
Private Yenisehir Hospital
City
Mersin
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ertan Yetkin, MD
Phone
905327136721
Email
ertanyetkin@hotmail.com
First Name & Middle Initial & Last Name & Degree
Ertan Yetkin, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The results will be made available within 6 months of study completion
Citations:
PubMed Identifier
25828141
Citation
Ozturk S, Yalvac HD, Sivri N, Ozturk HM, Kilic Y, Bulut E, Celik A, Barlas Y, Tengiz I, Yetkin E. Anxiety and depression scores in patients with coronary artery disease and coronary artery ectasia. Int J Cardiol. 2015;186:299-301. doi: 10.1016/j.ijcard.2015.03.305. Epub 2015 Mar 20. No abstract available.
Results Reference
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PubMed Identifier
25438211
Citation
Yalvac D, Ozturk S, Sivri N, Kilic Y, Bulut E, Celik A, Barlas Y, Tengiz I, Yetkin E. Effects of patients anxiety and depression scores on coronary flow in patients with normal coronary arteries. Int J Cardiol. 2015 Feb 1;180:55-7. doi: 10.1016/j.ijcard.2014.11.153. Epub 2014 Nov 26. No abstract available.
Results Reference
background
PubMed Identifier
17453130
Citation
Yetkin E, Waltenberger J. Novel insights into an old controversy: is coronary artery ectasia a variant of coronary atherosclerosis? Clin Res Cardiol. 2007 Jun;96(6):331-9. doi: 10.1007/s00392-007-0521-0. Epub 2007 Apr 26.
Results Reference
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Evaluation of Emotional Status and Coronary Flow Characteristics by TIMI Frame Count Method

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