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

NCT ID: NCT02831153

Last Updated: 2016-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

2000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2017-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Artery Disease Coronary Artery Ectasia Slow-Flow Phenomenon Endothelial Dysfunction Anxiety Depression

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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normal coronary anatomy

coronary angiography will be performed by transfemoral or transradial route.

Group Type ACTIVE_COMPARATOR

coronary angiography

Intervention Type PROCEDURE

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.

coronary artery ectasia

coronary angiography will be performed by transfemoral or transradial route.

Group Type ACTIVE_COMPARATOR

coronary angiography

Intervention Type PROCEDURE

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.

slow coronary flow

coronary angiography will be performed by transfemoral or transradial route.

Group Type ACTIVE_COMPARATOR

coronary angiography

Intervention Type PROCEDURE

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.

nonobstructive coronary artery disease

coronary angiography will be performed by transfemoral or transradial route.

Group Type ACTIVE_COMPARATOR

coronary angiography

Intervention Type PROCEDURE

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.

obstructive coronary artery disease

coronary angiography will be performed by transfemoral or transradial route.

Group Type ACTIVE_COMPARATOR

coronary angiography

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abant Izzet Baysal University

OTHER

Sponsor Role collaborator

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

OTHER

Sponsor Role collaborator

Ankara City Hospital Bilkent

OTHER

Sponsor Role collaborator

Private Yenisehir Hospital

UNKNOWN

Sponsor Role collaborator

Private Gozde Hospital

UNKNOWN

Sponsor Role collaborator

Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

OTHER

Sponsor Role collaborator

Ertan YETKIN

OTHER

Sponsor Role lead

Responsible Party

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Ertan YETKIN

Director, Clinical Research

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Gulhane Military Medical Academy

Ankara, Kecioren, Turkey (Türkiye)

Site Status RECRUITING

Ankara Numune Training and Research Hospital

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Ankara Research and Training Hospital

Ankara, , Turkey (Türkiye)

Site Status ACTIVE_NOT_RECRUITING

Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Ankara, , Turkey (Türkiye)

Site Status ACTIVE_NOT_RECRUITING

Private Gözde Hospital

Malatya, , Turkey (Türkiye)

Site Status RECRUITING

Private Yenisehir Hospital

Mersin, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Ertan Yetkin, MD

Role: CONTACT

905327136721

Selcuk Ozturk, MD

Role: CONTACT

905535376613

Facility Contacts

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Turgay Celik, MD

Role: primary

905326731032

Mehmet Ileri, MD

Role: primary

Role: backup

Izzet Tandogan, MD

Role: primary

Ertan Yetkin, MD

Role: primary

905327136721

References

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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.

Reference Type BACKGROUND
PMID: 25828141 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25438211 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17453130 (View on PubMed)

Other Identifiers

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Vasmol001

Identifier Type: -

Identifier Source: org_study_id

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