Evaluation of Emotional Status and Coronary Flow Characteristics by TIMI Frame Count Method
STRAIN-TIMI
Effects of Emotional Status on Coronary Flow in Patients Undergoing Coronary Angiography:Multicenter TIMI Frame Count Assessment Study (STRAIN-TIMI Study)
1 other identifier
interventional
2,000
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable coronary-artery-disease
Started Jul 2016
Shorter than P25 for not_applicable coronary-artery-disease
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2016
CompletedFirst Submitted
Initial submission to the registry
July 10, 2016
CompletedFirst Posted
Study publicly available on registry
July 13, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedJuly 13, 2016
July 1, 2016
1 year
July 10, 2016
July 10, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
TIMI frame count method analysis
1 day
Study Arms (5)
normal coronary anatomy
ACTIVE COMPARATORcoronary angiography will be performed by transfemoral or transradial route.
coronary artery ectasia
ACTIVE COMPARATORcoronary angiography will be performed by transfemoral or transradial route.
slow coronary flow
ACTIVE COMPARATORcoronary angiography will be performed by transfemoral or transradial route.
nonobstructive coronary artery disease
ACTIVE COMPARATORcoronary angiography will be performed by transfemoral or transradial route.
obstructive coronary artery disease
ACTIVE COMPARATORcoronary angiography will be performed by transfemoral or transradial route.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Patients whom planned elective coronary angiography and accept to be included in the study as a participant
You may not qualify if:
- \< 18 years, history of prior coronary angiography, history of coronary artery revascularization, acute coronary syndrome patients, atrial fibrillation, heart failure, known systemic diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ertan YETKINlead
- Abant Izzet Baysal Universitycollaborator
- Saglik Bilimleri Universitesi Gulhane Tip Fakultesicollaborator
- Ankara City Hospital Bilkentcollaborator
- Private Yenisehir Hospitalcollaborator
- Private Gozde Hospitalcollaborator
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospitalcollaborator
Study Sites (6)
Gulhane Military Medical Academy
Ankara, Kecioren, Turkey (Türkiye)
Ankara Numune Training and Research Hospital
Ankara, Turkey (Türkiye)
Ankara Research and Training Hospital
Ankara, Turkey (Türkiye)
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Ankara, Turkey (Türkiye)
Private Gözde Hospital
Malatya, Turkey (Türkiye)
Private Yenisehir Hospital
Mersin, Turkey (Türkiye)
Related Publications (3)
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.
PMID: 25828141BACKGROUNDYalvac 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.
PMID: 25438211BACKGROUNDYetkin 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.
PMID: 17453130BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director, Clinical Research
Study Record Dates
First Submitted
July 10, 2016
First Posted
July 13, 2016
Study Start
July 1, 2016
Primary Completion
July 1, 2017
Study Completion
July 1, 2017
Last Updated
July 13, 2016
Record last verified: 2016-07
Data Sharing
- IPD Sharing
- Will share
The results will be made available within 6 months of study completion