The "CAD-Man" EXTEND Study (CAD-Man-EXTEND)

March 18, 2026 updated by: Marc Dewey, Charite University, Berlin, Germany

A Randomized, Controlled Trial in Patients With Suspected Coronary Artery Disease Based on Acute or Chronic Atypical Angina Pectoris - EXTEND

CAD-Man Extend is the long-term follow-up (clinical, laboratory, and computed tomography (CT) imaging) of a single-center, randomized, controlled CAD-Man trial comparing a CT-first strategy with a direct- invasive coronary angiography (ICA) diagnostic and management strategy, in 329 patients clinically referred for ICA with atypical angina or chest pain.

Overall goal:

The extension of CAD-Man follow-up (clinical, laboratory, and CT imaging) to approximately 10 years will provide the opportunity to compare plaque burden with CT-guided management versus direct-ICA at long-term and other endpoints.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The CAD-Man (Coronary Artery Disease Management with Multislice Computed Tomography and Magnetic Resonance Imaging in Patients with Atypical Angina Pectoris) trial evaluated whether computed tomography (CT) or invasive coronary angiography (ICA) should be performed in patients clinically referred for coronary angiography with an intermediate probability of coronary artery disease. Patients with suspected CAD were randomized 1:1 ratio to CT, followed by ICA if positive for obstructive CAD, or to direct ICA. In both tests, obstructive CAD was defined as at least a 50% diameter stenosis in the left main coronary artery or at least a 70% diameter stenosis in other coronary arteries. Investigators and participants were blinded to randomization sequence but could not be blinded to the assigned group because of the apparent differences between CT and ICA. Independent investigators, who were blinded to the randomization group and were not part of the study team, anonymously assessed outcomes. Results on the comparative effectiveness of CT and ICA in preventing the primary outcome of major procedural complications within 48 hours of the last procedure and major adverse events (defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke) were published for a median follow-up of 3.3 years.

The primary results and additional subgroup analyses of the CAD-Man trial led to three new hypotheses that will be evaluated in the CAD-Man Extend study.

  1. Main hypothesis:

    Whether CT-guided management of patients with atypical angina results in a reduction in coronary plaque burden (as determined by repeat CT scan) compared with direct-ICA management until 10 years.

  2. Secondary hypothesis:

1. Whether clinical characteristics or blood levels and lipid-lowering medications have an impact on intraindividual progression of coronary plaques in patients in the CT group.

2. Whether primary CT examination in patients with atypical angina leads to a reduction in chronic impairment of renal function after 10-years compared with initial ICA examination.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
318

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Charité - Universitätsmedizin Berlin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with suspected CAD
  • Patients with atypical angina
  • Patients who have previously participated in the CAD-Man study and have not died at a median follow-up of 3.3 years.

Exclusion Criteria:

Exclusion criteria for additional CT scan:

  • Pregnancy
  • Any health condition that would cause concern that participation would not be in the best interest of health (eg, extensive comorbidities)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: CT
CT-directed clinical management strategy
Diagnostic test: CT
CT-directed clinical management strategy
Active Comparator: Invasive coronary angiography (ICA)
Standard clinical management directed by conventional invasive coronary angiography (ICA).
Diagnostic test: invasive coronary angiography (ICA)
Standard clinical management directed by conventional invasive coronary angiography (ICA).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Comparison of coronary plaque burden (non-calcified plaque volume (NCPV) measured by CT at 10-years between the initial randomization CT and ICA groups
Time Frame: at 10 years
at 10 years
Comparison of coronary plaque burden total plaque volume (TPV)) measured by CT at 10-years between CT and ICA groups
Time Frame: at 10 years
at 10 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Intraindividual progression of coronary artery disease (defined as change in coronary plaque burden from the first CT until the CT examination after 10 years) in the CT group.
Time Frame: at 10 years
at 10 years
Comparison of the difference in chronic kidney injury, (eGFR and as increase in creatinine by 25% or 0.5 mg/dl) in both groups at 10-year follow-up between CT and ICA groups.
Time Frame: at 10 years
at 10 years

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To compare minor cardiovascular events at final follow-up (after approximately 10 years).
Time Frame: at 10 years
Cardiovascular events (unstable angina pectoris, re-revascularization, and first revascularization at least 2 months after randomization)
at 10 years
To compare the cost-effectiveness in both groups. (after 10 years).
Time Frame: at 10 years
To compare cost-effectiveness in both groups using the quality-adjusted life year data, and cost data derived from the trial.
at 10 years
Comparison of two types of structured reports one medical and one using easy language (according to the german clinical practice guidelines) using patient acceptance questionnaire.
Time Frame: at 10 years
at 10 years
To compare cholesterol level (LDL, HDL, Triglycerin) between the initial randomization CT and ICA groups.
Time Frame: at 10 years
at 10 years
Comparison of statin use (proportion) between the initial randomization CT and ICA groups.
Time Frame: at 10 years
at 10 years
Effect of statins on coronary plaque burden (non-calcified plaque volume (NCPV) )measured by CT at 10-years in CT group
Time Frame: at 10 years
at 10 years
Effect of statins on coronary plaque burden (total plaque volume (TPV)) measured by CT at 10-years in CT group
Time Frame: at 10 years
at 10 years
To compare calcified plaque volume at 10-years between CT and ICA group
Time Frame: at 10 years
at 10 years
To compare low-attenuation plaque volume (LAPV) at 10-years between CT and ICA group
Time Frame: at 10 years
at 10 years
To compare percentage atheroma volume (PAV) at 10-years between CT and ICA group
Time Frame: at 10 years
at 10 years
To compare relative plaque volume at 10-years between CT and ICA group
Time Frame: at 10 years
at 10 years
To compare segment stenosis score (SSS) at 10-years between CT and ICA group
Time Frame: at 10 years
at 10 years
To compare segment involvement score (SIS) at 10-years between CT and ICA group
Time Frame: at 10 years
at 10 years
To compare stenosis at 10-years between CT and ICA group
Time Frame: at 10 years
Stenosis (no stenosis, <20%, 20 to 50%, >50%)
at 10 years
To compare plaque composition at 10-years between CT and ICA group
Time Frame: at 10 years
(calcified, non-calcified (fibrous, fibrofatty, lipid-rich), partially calcified)
at 10 years
To compare high-risk plaque (HRP) features at 10-years between CT and ICA group
Time Frame: at 10 years
(HRP; positive remodelling (PR), napkin ring sign, spotty calcification, low attenuation (LAP)
at 10 years
To analyze the impact of baseline cardiovascular risk factors on non-calcified plaque volume (NCPV) in the CT Group
Time Frame: at 10 years

Age (< 65, 65-75, > 75)

Body Mass Index (BMI) (< 25, 25-30, > 30) Gender (male versus female) Diabetes (yes/no)
at 10 years
To analyze the impact of baseline cardiovascular risk factors on total plaque volume (TPV) in the CT Group
Time Frame: at 10 years

Age (< 65, 65-75, > 75)

Body Mass Index (BMI) (< 25, 25-30, > 30) Gender (male versus female) Diabetes (yes/no)
at 10 years
To analyze the impact of nutrition on non-calcified plaque volume (NCPV) in the CT Group
Time Frame: at 10 years
at 10 years
To analyze the impact of nutrition on total plaque volume (TPV) in the CT Group
Time Frame: at 10 years
at 10 years
To analyze the impact of physical activity (Freiburg questionnaire) on non-calcified plaque volume (NCPV) in the CT Group
Time Frame: at 10 years
at 10 years
To analyze the impact of physical activity (Freiburg questionnaire) on total plaque volume (TPV) in the CT Group
Time Frame: at 10 years
at 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Charite University, Berlin, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 11, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 29, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 20, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 1, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EA1/124/23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We will share individual patient data from CAD-Man extend study via the GUIDE-IT platform.

IPD Sharing Time Frame

12 months after publication. End 3 years after publication

IPD Sharing Access Criteria

Researchers who provide a methodologically sound proposal approved by the Dissemination Committee of CAD-Man and GUIDE-IT.

The study proposal must include: The proposed study's overview, rationale, aims and analysis methods, plans for dissemination of results and names of those wishing to access data, and how is the data going to be stored and for how long.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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