Evaluation of Emotional Status and Coronary Flow Characteristics by TIMI Frame Count Method

Depression Clinical Trial

— 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02831153
• Other study ID #: Vasmol001
• Status: Recruiting
• Phase: N/A
• First received: July 10, 2016
• Last updated: July 10, 2016
• Start date: July 2016
• Est. completion date: July 2017

Study information

• Verified date: July 2016
• Source: Vascular and Molecular Cardiology Society
• Contact: Ertan Yetkin, MD
• Phone: 905327136721
• Email: ertanyetkin[@]hotmail.com
• Is FDA regulated: No
• Health authority: Turkey: Ethics CommitteeTurkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Anxiety
• Coronary Artery Disease
• Coronary Artery Ectasia
• Coronary Disease
• Depression
• Endothelial Dysfunction
• Myocardial Ischemia
• No-Reflow Phenomenon
• Slow-Flow Phenomenon

Intervention

Procedure:
• coronary angiography
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.

Locations

Country	Name	City	State
Turkey	Ankara Numune Training and Research Hospital	Ankara
Turkey	Ankara Research and Training Hospital	Ankara
Turkey	Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital	Ankara
Turkey	Gulhane Military Medical Academy	Ankara	Kecioren
Turkey	Private Gözde Hospital	Malatya
Turkey	Private Yenisehir Hospital	Mersin

Sponsors (7)

Lead Sponsor	Collaborator
Ertan YETKIN	Abant Izzet Baysal University, Ankara Numune Training and Research Hospital, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital, Gulhane Military Medical Academy, Private Gozde Hospital, Private Yenisehir Hospital

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

Yalvac D, Ozturk S, Sivri N, Kiliç 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. — View 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. Epub 2007 Apr 26. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TIMI frame count method analysis		1 day	Yes