## Protocol Section
### Identification Module
**NCT ID:** NCT01190579

**Acronym:** MEDIC

**Brief Title:** Dual Source CT Angiography for Detection of Coronary Artery Stenoses

**Official Title:** Multicenter Evaluation of Coronary Dual Source CT Angiography in Patients With Intermediate Risk of Coronary Artery Stenoses

#### Organization Study ID Info
**ID:** MEDIC
#### Organization
**Class:** OTHER
**Full Name:** University of Erlangen-Nürnberg Medical School
### Status Module
#### Completion Date
**Date:** 2010-12

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2010-08-27

**Type:** ESTIMATED

**Last Update Submit Date:** 2010-08-26

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2010-12

**Type:** ESTIMATED

#### Start Date
**Date:** 2009-08

**Status Verified Date:** 2010-08

#### Study First Post Date
**Date:** 2010-08-27
**Type:** ESTIMATED
**Study First Submit Date:** 2010-08-20
**Study First Submit QC Date:** 2010-08-26
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Siemens Medical Solutions

**Class:** INDUSTRY

**Name:** Bayer

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Erlangen-Nürnberg Medical School

#### Responsible Party

**Old Name Title:** Stephan Achenbach

**Old Organization:** University of Erlangen-Nürnberg Medical School

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The trial will investigate the accuracy of Dual Source CT coronary angiography to detect coronary artery stenoses in patients with chest pain who have, based on clinical criteria, an intermediate likelihood for the presence of coronary artery stenoses. No beta blockers will be used to lower the heart rate for the examination. The hypothesis is that Dual Source CT will allow the detection of vessels with at least one coronary artery stenosis with a sensitivity of more than 90%.

### Conditions Module

**Conditions:**

- Coronary Artery Disease

**Keywords:**

- Coronary Artery Disease

- Chest Pain

- Computed Tomography

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 398

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Outcomes Module

#### Primary Outcomes

**Description:** Invasive coronary angiography will be preformed within 72 hours to verify coronary CT angiography results.

**Measure:** Accuracy for the detection of coronary artery stenoses

**Time Frame:** 72 hours

#### Secondary Outcomes

**Description:** Patients will be monitored for one hour after injection of Ultravist 370 and Ultravist 300 intravenously to assess safety and detect side effects.

**Measure:** Safety of Ultravist 370 and Ultravist 300 for coronary CT angiography

**Time Frame:** 1 hour

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* suspected coronary artery disease
* chest Pain
* intermediate likelihood of coronary stenoses
* planned invasive coronary angiography
* age 30 to 80 years

Exclusion Criteria:

* non sinus rhythm
* contrast allergy
* renal failure
* unstable clinical condition
* previous coronary revascularization
* calcium score exceeding 800
* inability to perform 10 second breathhold
* possible pregnancy
* metformin medication that cannot be interrupted
* inability to establish antecubital iv access

**Maximum Age:** 80 Years

**Minimum Age:** 30 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Patients with Chest Pain and an Intermdiate Likelihood for Coronary Artery Stenoses

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** stephan.achenbach@uk-erlangen.de

**Name:** Stephan Achenbach, MD

**Phone:** ++49 9131 8535000

**Role:** CONTACT

**Contact 2:**

**Email:** dieter.ropers@uk-erlangen.de

**Name:** Dieter Ropers, MD

**Phone:** ++49 9131 8535301

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Vejle

**Contacts:**

***Contact 1:***

- **Name:** Kristian Ovrehus, MD

- **Role:** CONTACT

**Country:** Denmark

**Facility:** Vejle Medical Center

**Status:** RECRUITING

**Location 2:**

**City:** Erlangen

**Contacts:**

***Contact 1:***

- **Email:** stephan.achenbach@uk-erlangen.de

- **Name:** Stephan Achenbach, MD

- **Phone:** ++49 9131 8535000

- **Role:** CONTACT

***Contact 2:***

- **Name:** Stephan Achenbach, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Germany

**Facility:** University of Erlangen

**Status:** RECRUITING

**Location 3:**

**City:** Hamburg

**Contacts:**

***Contact 1:***

- **Name:** Joern Sandstede

- **Role:** CONTACT

**Country:** Germany

**Facility:** Roentgenpraxis Hamburg

**Status:** RECRUITING

**Location 4:**

**City:** Muenchen

**Contacts:**

***Contact 1:***

- **Email:** joerg.hausleiter@dhm.mhn.de

- **Name:** Joerg Hausleiter, MD

- **Role:** CONTACT

***Contact 2:***

- **Name:** Joerg Hausleiter, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Germany

**Facility:** Deutsches Herzzentrum Muenchen

**Status:** RECRUITING

**Location 5:**

**City:** Munich

**Contacts:**

***Contact 1:***

- **Name:** Christoph Becker, MD

- **Role:** CONTACT

**Country:** Germany

**Facility:** Klinikum Grosshadern

**Status:** NOT_YET_RECRUITING

**Location 6:**

**City:** Hyderabad

**Contacts:**

***Contact 1:***

- **Name:** Ravi Bathina, MD

- **Role:** CONTACT

**Country:** India

**Facility:** Ravi Bathina

**Status:** RECRUITING

**Location 7:**

**City:** Monterrey

**Contacts:**

***Contact 1:***

- **Name:** Erasmo De La Pena, MD

- **Role:** CONTACT

**Country:** Mexico

**Facility:** Cardiovascular Institute

**Status:** RECRUITING

**Location 8:**

**City:** Singapore

**Contacts:**

***Contact 1:***

- **Name:** Keng Thye Ho, MD

- **Role:** CONTACT

**Country:** Singapore

**Facility:** Tan Tok Seng Hospital

**Status:** RECRUITING

#### Overall Officials

**Official 1:**

**Affiliation:** University of Erlangen-Nürnberg

**Name:** Stephan Achenbach, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000001161

- Term: Arteriosclerosis

- ID: D000001157

- Term: Arterial Occlusive Diseases

- ID: D000014652

- Term: Vascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M6549

- Name: Coronary Disease

- Relevance: HIGH

- As Found: Coronary Artery Disease

- ID: M6546

- Name: Coronary Artery Disease

- Relevance: HIGH

- As Found: Coronary Artery Disease

- ID: M19506

- Name: Myocardial Ischemia

- Relevance: HIGH

- As Found: Coronary Artery Disease

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M6475

- Name: Constriction, Pathologic

- Relevance: LOW

- As Found: Unknown

- ID: M22913

- Name: Coronary Stenosis

- Relevance: HIGH

- As Found: Coronary Artery Stenosis

- ID: M5882

- Name: Chest Pain

- Relevance: LOW

- As Found: Unknown

- ID: M10543

- Name: Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4469

- Name: Arteriosclerosis

- Relevance: LOW

- As Found: Unknown

- ID: M4465

- Name: Arterial Occlusive Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003324

- Term: Coronary Artery Disease

- ID: D000017202

- Term: Myocardial Ischemia

- ID: D000003327

- Term: Coronary Disease

- ID: D000023921

- Term: Coronary Stenosis

### Misc Info Module

- Version Holder: 2024-05-24
