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

Sponsor

Ertan YETKIN (Other)

Overall Status

Unknown status

CT.gov ID

NCT02831153

Collaborator

Abant Izzet Baysal University (Other), Saglik Bilimleri Universitesi Gulhane Tip Fakultesi (Other), Ankara City Hospital Bilkent (Other), Private Yenisehir Hospital (Other), Private Gozde Hospital (Other), Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital (Other)

2,000

Enrollment

Locations

Arms

Duration (Months)

333.3

Patients Per Site

27.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease Coronary Artery Ectasia Slow-Flow Phenomenon Endothelial Dysfunction Anxiety Depression	Procedure: coronary angiography	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

2000 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

Triple (Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Diagnostic

Official Title:

Effects of Emotional Status on Coronary Flow in Patients Undergoing Coronary Angiography:Multicenter TIMI Frame Count Assessment Study (STRAIN-TIMI Study)

Study Start Date :

Jul 1, 2016

Anticipated Primary Completion Date :

Jul 1, 2017

Anticipated Study Completion Date :

Jul 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: normal coronary anatomy coronary angiography will be performed by transfemoral or transradial route.	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.
Active Comparator: coronary artery ectasia coronary angiography will be performed by transfemoral or transradial route.	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.
Active Comparator: slow coronary flow coronary angiography will be performed by transfemoral or transradial route.	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.
Active Comparator: nonobstructive coronary artery disease coronary angiography will be performed by transfemoral or transradial route.	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.
Active Comparator: obstructive coronary artery disease coronary angiography will be performed by transfemoral or transradial route.	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.

Outcome Measures

Primary Outcome Measures

TIMI frame count method analysis [1 day]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country
1	Gulhane Military Medical Academy	Ankara	Kecioren	Turkey
2	Ankara Numune Training and Research Hospital	Ankara		Turkey
3	Ankara Research and Training Hospital	Ankara		Turkey
4	Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital	Ankara		Turkey
5	Private Gözde Hospital	Malatya		Turkey
6	Private Yenisehir Hospital	Mersin		Turkey

Sponsors and Collaborators

Ertan YETKIN
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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Ertan YETKIN, Director, Clinical Research, Vascular and Molecular Cardiology Society

ClinicalTrials.gov Identifier:

NCT02831153

Other Study ID Numbers:

Vasmol001

First Posted:

Jul 13, 2016

Last Update Posted:

Jul 13, 2016

Last Verified:

Jul 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Additional relevant MeSH terms:

Coronary Artery Disease

Coronary Aneurysm

No-Reflow Phenomenon

Study Results

No Results Posted as of Jul 13, 2016