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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02831153
Other study ID # Vasmol001
Secondary ID
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


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
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