Mechanical Complications of Acute Myocardial Infarction: a Multicenter Prospective Study

NCT06676345 | Recruiting

• 1 other identifier: IT-VA:56/2024
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

In 2019, the international study titled "CAUTION Study - 1" (MeChanical complicAtions of acUte myocardial infarcTion: an InternatiOnal multiceNter cohort study), a retrospective multicenter study, was launched and registered on ClinicalTrials.gov (Identifier: NCT03848429). This study highlighted the outcomes of surgical treatment of post-infarction mechanical complications in patients operated between 2000 and 2019. Several scientific publications have resulted from this registry, which involved 27 international centers and recruited about 800 patients. However, retrospective studies are inherently limited by factors such as selection bias and a high number of missing data, affecting data interpretation and consistency of results. Moreover, most registries report only data about surgical patients or, in rare situations, about patients treated percutaneously. To overcome these limitations, a prospective study has been designed to collect more precise and focused data and achieve results that better reflect the current clinical practice, including all the patients diagnosed with post-infarction mechanical complications, independently from the treatment assigned. "CAUTION Study - 2" is, therefore, a prospective, multicenter cohort study with the primary aim of analyzing the outcomes of surgical, percutaneous and conservative treatment of post-infarction mechanical complications in the contemporary era.

Conditions

Ventricular Septal Defect; Papillary Muscle Rupture; Cardiac Rupture; Pseudoaneurysm

Outcome Measures

Primary Outcomes (1)

• In-hospital mortality

  Mortality during the hospitalization for the management of post-infarction mechanical complication

  from enrollment to the end of hospitalization (up to 30 days)

Secondary Outcomes (1)

• Long-term survival

  from enrollment to the end of follow-up (5 years from diagnosis)

Study Arms (1)

Patients with post-infarction mechanical complications

All the patients diagnosed with post-infarction mechanical complications, independently from the treatment assigned (surgical, percutaneous or conservative)

Procedure: Surgical treatment; Procedure: Percutaneous treatment

Interventions

Surgical treatment PROCEDURE

Surgical repair of post-infarction mechanical complications (e.g. sutureless or sutured repair for LVFWR, David or Daggett technique for VSR, mitral valve repair or replacement for PMR)

Patients with post-infarction mechanical complications

Percutaneous treatment PROCEDURE

Percutaneous approach for the management of post-infarction mechanical complications (e.g. percutaneous closure with device for VSR, Mitraclip for PMR, PIFIT for LVFWR)

Patients with post-infarction mechanical complications

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients diagnosed with post-infarction mechanical complications

You may qualify if:

• all the patients diagnosed with post-infarction mechanical complications, independently from the treatment assigned

You may not qualify if:

• patients with cardiac rupture not acute myocardial infarction related

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

ASST dei Sette Laghi

Varese, Italy

RECRUITING

Related Publications (3)

• Ronco D, Matteucci M, Kowalewski M, De Bonis M, Formica F, Jiritano F, Fina D, Folliguet T, Bonaros N, Russo CF, Sponga S, Vendramin I, De Vincentiis C, Ranucci M, Suwalski P, Falcetta G, Fischlein T, Troise G, Villa E, Dato GA, Carrozzini M, Serraino GF, Shah SH, Scrofani R, Fiore A, Kalisnik JM, D'Alessandro S, Lodo V, Kowalowka AR, Deja MA, Almobayedh S, Massimi G, Thielmann M, Meyns B, Khouqeer FA, Al-Attar N, Pozzi M, Obadia JF, Boeken U, Kalampokas N, Fino C, Simon C, Naito S, Beghi C, Lorusso R. Surgical Treatment of Postinfarction Ventricular Septal Rupture. JAMA Netw Open. 2021 Oct 1;4(10):e2128309. doi: 10.1001/jamanetworkopen.2021.28309.

  PMID: 34668946 BACKGROUND

• Matteucci M, Ronco D, Kowalewski M, Massimi G, De Bonis M, Formica F, Jiritano F, Folliguet T, Bonaros N, Sponga S, Suwalski P, De Martino A, Fischlein T, Troise G, Dato GA, Serraino FG, Shah SH, Scrofani R, Kalisnik JM, Colli A, Russo CF, Ranucci M, Pettinari M, Kowalowka A, Thielmann M, Meyns B, Khouqeer F, Obadia JF, Boeken U, Simon C, Naito S, Musazzi A, Lorusso R. Long-term survival after surgical treatment for post-infarction mechanical complications: results from the Caution study. Eur Heart J Qual Care Clin Outcomes. 2024 Dec 19;10(8):737-749. doi: 10.1093/ehjqcco/qcae010.

  PMID: 38327179 BACKGROUND

• Matteucci M, Kowalewski M, De Bonis M, Formica F, Jiritano F, Fina D, Meani P, Folliguet T, Bonaros N, Sponga S, Suwalski P, De Martino A, Fischlein T, Troise G, Dato GA, Serraino GF, Shah SH, Scrofani R, Antona C, Fiore A, Kalisnik JM, D'Alessandro S, Villa E, Lodo V, Colli A, Aldobayyan I, Massimi G, Trumello C, Beghi C, Lorusso R. Surgical Treatment of Post-Infarction Left Ventricular Free-Wall Rupture: A Multicenter Study. Ann Thorac Surg. 2021 Oct;112(4):1186-1192. doi: 10.1016/j.athoracsur.2020.11.019. Epub 2020 Dec 9.

  PMID: 33307071 BACKGROUND

MeSH Terms

Conditions

Heart Septal Defects, Ventricular; Heart Rupture; Aneurysm, False

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Vascular Diseases

Central Study Contacts

Matteo Matteucci, MD, PhD

CONTACT

+39.3493556001; matteomatteucci87@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2024
• First Posted: November 6, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2032
• Last Updated: May 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)