Health TrialsbyHealthPanel

Improved Management of Patients With Recent-Onset Stable Chest Pain

ConditionCoronary Artery Disease (CAD)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30+
SponsorPhilipps University Marburg

About this trial

In Germany, coronary CT offers an accurate and less burdensome alternative to cardiac catheterisation for evaluating suspected coronary artery disease, but it is still underused. The IMPRO stepped-wedge trial tests a new, nationwide care model (NVF) in 16 regions to improve guideline-based intersectoral implementation of coronary CT and assess its impact on cardiovascular outcomes and healthcare costs. If effective, the model of care (NVF) could be adopted across Germany to enhance care quality while reducing unnecessary procedures and expenses.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥30 years

Suspected CAD with stable chest pain

Ability to give informed consent

Disqualifiers

Known or previously treated (with PCI or CABG) obstructive CAD (defined as at least one coronary diameter stenosis ≥50%)

Acute coronary syndrome

Negative invasive coronary angiography or coronary CT within the last 5 years

Already enrolled in the study

Trial design

Design model

Sequential

Treatments tested in this trial

  • IMPRO - Cross-Sectoral Care Model for Coronary Diagnostics

    Behavioral

    The intervention consists of structural and procedural components designed to improve cross-sectoral coordination in the diagnostic work-up of patients with suspected coronary artery disease (CAD). It builds upon the 2024 National Disease Management Guideline (NVL KHK 2024) and comprises three main components: (1) evidence-based initial assessment and indication for imaging diagnostics, (2) shared decision-making between primary care physicians, radiologists, and patients, and (3) quality-assured CT imaging and structured reporting in certified centres. Participating sites receive structured training, feedback, and centralized quality monitoring.

Treatment groups

3,369 Participants
are divided into 2 treatment groups
Group A: Usual CareNo intervention 0 interventions
Group B: IMPRO ProgramExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Major Adverse Cardiovascular Events (MACE)

Composite endpoint: Major Adverse Cardiovascular Events (MACE) including cardiovascular death, myocardial infarction, stroke, and procedure-related complications from diagnostic testing and subsequent management/therapy in the two randomization groups. Procedure-related complications (major and minor) are defined in the subsequent outcome measure and include events occurring during or within 48 hours after CT or ICA or related tests or revascularization procedures.

Time frame
From enrolment to 12 months for primary MACE analysis in the G-BA-funded IMPRO trial; extended follow-up to 5 years for MACE (cardiovascular death, myocardial infarction, stroke) excluding procedure-related complications; data at 3, 12 months and 5 years

Secondary outcomes

1

Prospective Primary Safety Endpoint: Procedure-related Complications

Rate of procedure-related complications by diagnostic imaging modality and by interventional/surgical treatments (PCI, CABG). Includes major and minor complications. Major complications: events occurring during or within 48 hours after CT or ICA or related tests or revascularization procedures, including death, nonfatal myocardial infarction, nonfatal stroke, complications prolonging hospitalization ≥24 hours, coronary/aortic dissection, cardiogenic shock, cardiac tamponade, retroperitoneal bleeding, cardiac arrhythmia (ventricular tachycardia/fibrillation), or cardiac arrest. Minor complications: events occurring during or within 48 hours after CT or ICA or related tests or revascularization procedures not meeting major criteria, including hematoma or secondary bleeding at the puncture site, bradycardia, angina pectoris without myocardial infarction, allergic reaction to contrast media, hypotension requiring treatment, infection, thrombosis, or arteriovenous fistula.

Time frame
3 months and 12 months
2

Indication quality

1\) Agreement of the diagnostic decision with the pre-test probability (PTP, below 15%, 15-50%, above 50% criterion) with the National Health Services guidelines for suspected coronary artery disease and the statistical distribution of PTP values across the scale (NVL KHK 2024), measured using the updated DISCHARGE PTP calculator in the two randomisation groups, 2) Agreement of the mean pre-test probability with the prevalence of obstructive coronary artery disease (CAD) defined as at least one at least 50% coronary artery diameter stenosis on coronary computed tomography angiography (CTA) and/or invasive coronary angiography (ICA) in the two randomisation groups.

Time frame
From enrollment to 12 months (with follow-up data collection at baseline, 3 months, 12 months)
3

Functional test rates

Rate of functional tests performed during the follow-up period (stress electrocardiography (ECG), cardiac stress magnetic resonance imaging (MRI), stress echocardiography, stress myocardial perfusion single-photon emission CT (SPECT), myocardial stress perfusion positron emission tomography (PET)) in the two randomisation groups.

Time frame
From enrollment to 12 months and 5 years (with follow-up data collection at 3 months, 12 months and 5 years)
4

Revascularization rates

Rate of coronary artery revascularisations (percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG)) performed during the follow-up period in the two randomisation groups.

Time frame
From enrollment to 12 months and 5 years (with follow-up data collection at 3 months, 12 months and 5 years)

Other outcomes

1

Comparison of incidental findings on CT

Analysis of prevalence of a) non-coronary cardiac causes of symptoms (such as aortic dissection, valve disease, pericarditis) or b) non-cardiac causes of symptoms (such as thrombus, pulmonary embolism, pleural effusion, pneumonia, hiatal hernia) on CT in the two randomisation groups.

Time frame
3 months, 12 months, 5 years
2

Effects of incidental findings on CT

Influence of non-coronary cardiac and non-cardiac findings on MACE, non-cardiac events and Quality of Life (QoL) measured using EQ-5D-5L in the two randomisation groups.

Time frame
3 months, 12 months, 5 years
3

Malignant incidental findings

Rate for malignancy in pulmonary nodules seen on CT (reference standard: biopsy results in the two randomisation groups, Positron Emission Tomography (PET) findings, or progression versus no change or regression on follow-up CT).

Time frame
3 months, 12 months, 5 years
4

Rate of death from cancer

Rate of death from cancer in both randomisation groups.

Time frame
5 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Philipps University Marburg

Lead sponsor

Gemeinsamer Bundesaussschuss

Collaborator

Source ClinicalTrials.gov
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